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PRODIGE 76-IMMUNOBILADJ: Capecitabine plus durvalumab or capecitabine alone as adjuvant therapy in patients with resected biliary tract carcinoma. A non-comparative randomized phase II study
EU CTIS ID: 2023-503807-27-00
What this study is testing
To assess the disease-free survival rate at 18 months of durvalumab plus capecitabine in patients with resected Biliary Tract Carcinoma (The disease relapse will be defined by the appearance of local/ distant recurrence or 2nd primary biliary tract cancer by investigator’s evaluation).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
- Adequate organs functions
- Body weight > 30 kg
- Life expectancy ≥ 3 months
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female of childbearing potential and pre-menopausal patients.
- Patient affiliated to a social security scheme
You likely can't join if
- Previous neoadjuvant systemic chemotherapy or intra-arterial therapy (TACE, TAE, SIRT…) before surgery.
- Prior treatment with capecitabine or any immune ICI, including durvalumab or any other anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody
- Uncontrolled massive pleural effusion or massive ascites
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Immune hyperthyroitidis disease, rheumatoid arthritis, hypophysitis, uveitis, etc]), that has required systemic treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT-scan
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
See the full eligibility criteria
Who can join
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
- Adequate organs functions
- Body weight > 30 kg
- Life expectancy ≥ 3 months
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female of childbearing potential and pre-menopausal patients.
- Patient affiliated to a social security scheme
- Willing and able to comply with the protocol for the duration of the study including undergoing treatment (able to take medicinal products by mouth) and scheduled visits and examinations including follow up and for biological study.
- BTC (perihilar CCA, distal CCA, intrahepatic CCA, or gallbladder carcinoma) with complete macroscopic resection (R0/R1)
- No evidence of metastatic or recurrent disease on post-operative CT-scan (< 4 weeks before randomization)
- Surgery for primary tumour > 4 weeks and < 12 weeks prior to the first dose of investigational product
- Absence of dihydropyrimidine dehydrogenase (DPD) deficiency (defined by uracilemia < 16 ng/mL)
- Age ≥ 18 years
- Eastern Cooperative Oncology Group – Performance Status (ECOG – PS) 0-1
- Have archival tissue sample that has been identified and confirmed as available for study
What rules you out
- Previous neoadjuvant systemic chemotherapy or intra-arterial therapy (TACE, TAE, SIRT…) before surgery.
- Prior treatment with capecitabine or any immune ICI, including durvalumab or any other anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody
- Uncontrolled massive pleural effusion or massive ascites
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Immune hyperthyroitidis disease, rheumatoid arthritis, hypophysitis, uveitis, etc]), that has required systemic treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT-scan
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- Live vaccine administration within 30 days prior to the first dose of study treatment
- Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients (capecitabine or durvalumab)
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant, in the opinion of the treating investigator
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) or supportive care clinical study or during the follow-up period of an interventional study
- Pregnancy/lactation
- Tutelage or guardianship
- Participation in another clinical study with an investigational product during the last 4 weeks
- Child B or C cirrhosis
- Mixed histology (hepatocholangiocarcinoma)
- Ampullary carcinoma
- History of allogenic organ transplantation
- Unresolved post-operative complications that may be at risk for adjuvant therapy
- Any systemic steroid therapy (> 10 mg daily dose of prednisone or equivalent) whatever the duration of this corticotherapy
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), and Hepatitis B Virus (HBV)-Hepatitis C Virus (HCV) co-infection or HBV-HepD co-infection , or human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies)
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.