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    Summary
    EudraCT Number:2021-000588-53
    Sponsor's Protocol Code Number:SNIPER
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-000588-53
    A.3Full title of the trial
    RR001 in combination with chemotherapy for patients with locally advanced pancreatic adenocarcinoma: open-label, non-randomized dose escalation phase I/IIa study
    RR001 in combinazione con chemioterapia per pazienti con adenocarcinoma pancreatico localmente avanzato: studio di fase I / IIa di “dose escalation”, in aperto, non randomizzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gene therapy and chemotherapy for pancreatic cancer: clinical study of safety and efficacy
    Terapia genica e chemioterapia per il tumore pancreatico: studio clinico di sicurezza ed efficacia
    A.3.2Name or abbreviated title of the trial where available
    SNIPER
    SNIPER
    A.4.1Sponsor's protocol code numberSNIPER
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRIGENERAND Srl
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRIGENERAND SRL
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRIGENERAND srl
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressVia Maestri del Lavoro, 4
    B.5.3.2Town/ cityMedolla
    B.5.3.3Post code41043
    B.5.3.4CountryItaly
    B.5.4Telephone number3474014615
    B.5.6E-mailsimona.guidi@rigenerand.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2085
    D.3 Description of the IMP
    D.3.1Product nameCellule Umane Autologhe Adipose Stromali Perivascolari Geneticamente Modificate per la Secrezione di
    D.3.2Product code [RR001]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRR001
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number80000000 to 240000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberGene Therapy Medicinal Product EMA/416766/2017
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced pancreatic adenocarcinoma
    Adenocarcinoma pancreatico localmente avanzato
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer
    Tumore del pancreas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073364
    E.1.2Term Ductal adenocarcinoma of pancreas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety, feasibility of intra-tumoral injection of the RR001 administered by ultrasound (US) guided injections in combination with standard of care therapy based on GEM/Nab-PTX and to establish the maximal tolerated dose (MTD) and recommended phase IIb dose (RP2D) of intratumoral injections of RR001 after three dose levels delivery in combination with standard of chemotherapy
    Determinare la sicurezza, la fattibilità dell'iniezione intra-tumorale di RR001 somministrato mediante iniezioni ecoguidate (US) in combinazione con la terapia standard di cura basata su GEM / Nab-PTX e stabilire la dose massima tollerata (MTD) e la dose raccomandata di fase IIb (RP2D) delle iniezioni intratumorali di RR001 dopo tre livelli di dose erogati in combinazione con la chemioterapia standard
    E.2.2Secondary objectives of the trial
    1. Antitumor activity and response rate by RECIST 1.1 criteria
    2. Percentage of patients successfully undergoing to surgery and percentage of pathological resection (R0 vs. R1 vs. R2)
    3. Time to disease progression, progression free survival (PFS) and overall survival (OS)
    4. Quality of life (EORTC QLQ-C30, QLQ-PAN26)
    5. Exploratory endpoints (sTRAIL levels in serum and urine by ELISA, detection of sTRAIL encoding transgene in blood, urine and tumor biopsies by qPCR, histology on tumor biopsies, DPC4/SMAD4 status, radiological objectives)
    1. Effetto antitumorale e grado di risposta secondo i criteri RECIST1.1
    2. Percentuale di pazienti sottoposti con successo a intervento chirurgico e percentuale di resezione patologica (R0 vs. R1 vs. R2)
    3. Tempo alla progressione della malattia, sopravvivenza libera da progressione (PFS) e sopravvivenza globale (OS)
    4. Qualità della vita (EORTC QLQ-C30, QLQ-PAN26)
    5. Endpoint esploratori (Livelli di sTRAIL mediante ELISA nel plasma e nelle urine, rilevazione del transgene codificante sTRAIL nel sangue, nelle urine e nelle biopsie tumorali mediante qPCR, istologia su biopsie tumorali, stato DPC4 / SMAD4, obiettivi radiologici)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Patients with histologically and/or cytologically confirmed pancreatic ductal adenocarcinoma
    b) Patients with no evidence of peritoneal or hematogenous metastasis
    c) Patients classified as non-resectable locally advanced pancreatic carcinoma (LAPC) based on imaging (TC and NMR), on multidisciplinary staff evaluation by at least an oncologist, radiologist and a qualified digestive surgeon and accounting for AJCC/UICC TNM and clinical staging.
    d) Measurable tumor according RECIST criteria v 1.1
    e) Low tumor burden with at least one lesion equal/less than 3,5 cm that is suitable for US guided injection (and needle biopsy).
    f) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
    g) Patients must be eligible for standard of care treatment with GEM/Nab-PTX
    h) Patient older than 18 years of age
    i) Evidence of a personally signed and dated Ethical Committee-approved Informed consent form indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study
    j) Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN
    k) Adequate kidney function with serum creatinine <2 x the ULN or creatinine clearance >30 mL/min
    l) Absolute neutrophil count (ANC) =1.0 x 109/l, hemoglobin =9 g/dl, platelet count = 100 x 109/l, prothrombin (INR) <1.5.
    m) Life expectancy of at least 12 weeks
    n) Negative serum pregnancy test for females of childbearing potential within days of starting treatment
    o) Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate
    a) Pazienti con adenocarcinoma duttale pancreatico confermato istologicamente e / o citologicamente
    b) Pazienti senza evidenza di metastasi peritoneali o ematogene
    c) Pazienti classificati come carcinoma pancreatico localmente avanzato non resecabile (LAPC) sulla base di imaging (TC e NMR), sulla valutazione multidisciplinare da parte di almeno un oncologo, radiologo e un chirurgo qualificato e responsabile per la stadiazione AJCC / UICC TNM e clinica .
    d) Tumore misurabile secondo i criteri RECIST v 1.1
    e) Basso carico tumorale con almeno una lesione uguale / inferiore a 3,5 cm adatta per iniezione guidata ecografica (e biopsia con ago).
    f) Performance status dell'Eastern Cooperative Oncology Group (ECOG) 0, 1 o 2.
    g) Pazienti eleggibili per il trattamento standard di cura con GEM / Nab-PTX
    h) Paziente di età superiore a 18 anni
    i) Firma del modulo di consenso informato approvato dal Comitato Etico e datato personalmente indicante che il paziente (o un rappresentante legalmente riconosciuto) è stato informato di tutti gli aspetti pertinenti allo studio
    j) Adeguata funzionalità epatica, con bilirubina <1,5 x ULN e AST e ALT <2,5 x ULN
    k) Funzionalità renale adeguata con creatinina sierica <2 volte l'ULN o clearance della creatinina> 30 ml/min
    l) Conta assoluta dei neutrofili (ANC) =1,0 x 109 / l, emoglobina =9 g / dl, conta piastrinica = 100 x 109 / l, tempo di protrombina (INR) <1,5.
    m) Aspettativa di vita di almeno 12 settimane
    n) Test di gravidanza negativo per donne in età fertile entro pochi giorni dall'inizio del trattamento
    o) Disponibilità e capacità di rispettare le visite programmate, il piano di trattamento, le procedure di imaging, i test di laboratorio e altre procedure di studio, incluso il lipoaspirato
    E.4Principal exclusion criteria
    a) Female patients with childbearing age or pregnancy or breast feeding. Female patients shall agree to use effective contraception or be surgically sterile or postmenopausal.
    b) Patient with pancreatic cystic tumor or pancreatic pseudocyst
    c) Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastases)
    d) Patients with unknown stage or recurrent pancreatic cancer
    e) Patients with immunosuppression or susceptibility to viral infection
    f) Patients with HIV, hepatitis B, hepatitis C, HTLV-I/II, Treponema Pallidum infections
    g) Patients with liver cirrhosis or other documented liver diseases
    h) Patient contraindication to gemcitabine + nab-paclitaxel treatments
    i) Patients with not approachable US window for intratumoral injection of RR001 as evaluated by US examination of the abdomen
    j) Documented allergy to fluoroquinolones
    k) Previous of radiotherapy and chemotherapy for PDAC
    l) Previous haematopoietic stem cell or organ transplantation
    m) Irreversible cardiac arrhythmias requiring permanent medication
    n) Heart insufficiency (> grade II, New York Heart Association NYHA criteria)
    o) History within the last year of acute or subacute coronary cyndromes including myocardial infarction, unstable or severe stable angina pectoris
    p) Uncontrolled hypertension
    q) Patient not efficiently treated for jaundice (biliary stent or bypass) if present at time of diagnosis
    r) Other malignancies within the past 2 years (not including basal cell carcinoma of the skin, prostate cancer or in situ cervix carcinoma, in situ melanoma).
    s) Moderate to large volume ascites
    t) Active autoimmune disease
    u) Use of any investigational agents within 21 days from the administration of study treatment
    v) Patient has had major open surgery within the 3 months prior to the administration of study treatment
    w) Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that in the opinion of the Investigator would compromise compliance of study requirements or put the patient at unacceptable risk
    a) Pazienti di sesso femminile in età fertile o in gravidanza o allattamento. Le pazienti di sesso femminile devono accettare di utilizzare una contraccezione efficace o essere chirurgicamente sterili o in post-menopausa.
    b) Paziente con tumore cistico pancreatico o pseudocisti pancreatica
    c) Paziente con tumore pancreatico diverso da adenocarcinoma (endocrino, sede metastatica)
    d) Pazienti con carcinoma pancreatico in stadio sconosciuto o ricorrente
    e) Pazienti con immunosoppressione o suscettibilità alle infezioni virali
    f) Pazienti con infezioni da HIV, epatite B, epatite C, HTLV-I / II, Treponema Pallidum
    g) Pazienti con cirrosi epatica o altre malattie epatiche documentate
    h) Controindicazione del paziente ai trattamenti con GEM/ Nab-PTX
    i) Pazienti con finestra ecografica non accessibile per l'iniezione intra-tumorale di RR001, valutata mediante esame ecografico dell'addome
    j) Allergia documentata a fluorochinoloni
    k) Precedente radioterapia e chemioterapia for PDAC
    l) Precedente trapianto di cellule staminali emopoietiche o di organi
    m) Aritmie cardiache irreversibili che richiedono un trattamento permanente
    n) Insufficienza cardiaca (> grado II, criteri NYHA della New York Heart Association)
    o) Storia nell'ultimo anno di sindromi coronariche acute o subacute incluso infarto del miocardio, angina pectoris stabile o grave instabile
    p) Ipertensione incontrollata
    q) Paziente non trattato in modo efficiente per ittero (stent biliare o bypass) se presente al momento della diagnosi
    r) Altri tumori maligni negli ultimi 2 anni (esclusi carcinoma a cellule basali della pelle, cancro alla prostata o carcinoma della cervice in situ, melanoma in situ).
    s) Ascite di volume da moderato a grande
    t) Malattia autoimmune attiva
    u) Uso di qualsiasi agente sperimentale entro 21 giorni dalla somministrazione del trattamento in studio
    v) Il paziente ha subito un intervento chirurgico a cielo aperto maggiore nei 3 mesi precedenti la somministrazione del trattamento in studio
    w) Malattia intercorrente incontrollata inclusa ma non limitata a malattie psichiatriche / situazioni sociali che, a parere dello Sperimentatore, comprometterebbero la conformità ai requisiti dello studio o metterebbero il paziente a rischio inaccettabile
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoints will be feasibility and safety.
    Feasibility will be expressed as number of eligible patients receiving the gene therapy within 35 days from the liposuction. The intervention will be defined feasible if at least 80% of enrolled patients will be treated.
    Tolerability and safety will be expressed as number of patients recruited/treated experiencing any dose-limiting toxicity (DLT), adverse event (AE), adverse reaction (AR), unexpected adverse reaction (UAR), severe adverse event (SAE), suspected unexpected serious adverse reaction (SUSAR), or adverse event of special interest (AESI).
    Gli endpoint co-primari saranno fattibilità e sicurezza.
    La fattibilità sarà espressa come numero di pazienti eleggibili che ricevono la terapia genica entro 35 giorni dalla liposuzione. L'intervento sarà definito fattibile se verrà trattato con RR001 almeno l'80% dei pazienti arruolati.
    La tollerabilità e la sicurezza saranno espresse come numero di pazienti reclutati / trattati che hanno manifestato tossicità dose-limitante (DLT), evento avverso (EA), reazione avversa (AR), reazione avversa inattesa (UAR), evento avverso grave (SAE), sospetta reazione avversa grave inattesa (SUSAR) o evento avverso di particolare interesse (AESI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Feasibility will be evaluated for each patient between 46-57 days from enrollment and overall feasibility (at least 80% of patients treated with RR001) will be assessed at the end of study.
    Number and type of dose-limiting toxicities will be assessed at day +21 from RR001 injection for each patient.
    Safety endpoints related to RR001 will be evaluated after the infusion and until the end of study.
    Safety endpoints will be evaluated at the end of each DL group to determine any immediate AEs related to treatment and if stopping rules are met.
    Overall safety will be assessed by incidence of AEs and SAEs from the signature of the informed consent to the end of study.
    La fattibilità sarà valutata per ogni paziente dopo 46-57 giorni dall'arruolamento. La fattibilità complessiva (almeno l'80% dei pazienti trattati con RR001) sarà valutata alla fine dello studio.
    Il numero e il tipo di tossicità dose-limitanti saranno valutati al giorno +21 dall'iniezione di RR001 per ciascun paziente.
    Gli endpoint di sicurezza relativi a RR001 saranno valutati dopo l'infusione e fino alla fine dello studio.
    Gli endpoint di sicurezza saranno valutati alla fine di ogni livello di dose per determinare eventuali eventi avversi immediati correlati al trattamento e se vengono soddisfatte le regole di interruzione.
    La sicurezza complessiva sarà valutata in base all'incidenza di eventi avversi ed eventi avversi seri dalla firma del consenso informato fino alla fine dello studio.
    E.5.2Secondary end point(s)
    Changes in EORTC quality of life scores; Frequency and proportion of patients eligible for the surgery among those receiving the RR001 infusion; Changes in tumor markers (Ca 19.9, CEA); Frequency and proportion of patients not eligible for the surgery but reporting stable disease among those receiving the RR001 infusion; Mortality rate; Tumor response rate (RECIST criteria)
    Variazioni nei punteggi di qualità di vita EORTC; Frequenza e proporzione di pazienti eleggibili per l'intervento chirurgico tra quelli che ricevono l'infusione di RR001; Cambaimenti nei livelli di marker tumorali (Ca 19.9, CEA); Frequenza e proporzione di pazienti non eleggibili per l'intervento chirurgico ma che hanno riportato una malattia stabile tra quelli che hanno ricevuto l'infusione di RR001; Tasso di mortalità; Tasso di risposta tumorale (criteri RECIST)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to end of study; Visit 18 (after 21 days from RR001 administration); From baseline to end of study; Visit 22 (after 90 days from RR001 administration); 2, 4, 12 weeks after the RR001 infusion; From baseline to end-of-study
    Dal baseline alla fine dello studio; Visita 18 (dopo 21 giorni dalla somministrazione di RR001); Dal baseline alla fine dello studio; Visita 22 (dopo 90 giorni dalla somministrazione di RR001); Dopo 2, 4, 12 settimane dall'infusione di RR001; Dal baseline alla fine dello studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Dose-finding
    Dose-finding
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 9
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Three weeks after the infusion of gene therapy, based on the response to treatment, the multidisciplinary team will evaluate whether the patient will be able to undergo surgery for tumor resection or if he will need to be followed up with other therapeutic options (first or second line chemotherapy ). Both situations will be managed according to normal clinical practice to ensure the patient the best possible therapy in relation to tumor staging.
    Dopo tre settimane dall’infusione della terapia genica, il team multidisciplinare valuterà in base alla risposta al trattamento se il paziente potrà essere sottoposto a intervento chirurgico per la resezione del tumore o se dovrà essere seguito con altre opzioni terapeutiche (chemioterapia di prima o seconda linea). Entrambe le situazioni verranno gestite in base alla normale pratica clinica per assicurare al paziente la migliore terapia possibile in relazione alla stadiazione del tumore.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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