Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Canc… (NCT05771480) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
United States, France142 participantsStarted 2023-08-16
Plain-language summary
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
Who can participate
Age range18 Years – 130 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed, unresectable advanced or metastatic biliary tract carcinoma (BTC) including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma, and ampulla of Vater (AoV) carcinoma
* Participants with unresectable or metastatic BTC
* A World Health Organisation Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) of 0 to 2
* At least one lesion that qualifies as a Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) target lesion at baseline
* Adequate organ and bone marrow function
* Body weight of \> 30 kg
* Negative pregnancy test (serum) for women of childbearing potential
* Female participants must be one year post-menopausal (amenorrhoeic for 12 months without an alternative medical cause)
* Male and female participants and their partners must be surgically sterile or on their chosen method of birth control as per the protocol.
Exclusion Criteria:
* Any evidence of diseases such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diseases, active infection, active interstitial lung disease/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations, history of uncontrolled or symptomatic cardiac disease, and history of allogenic organ transplant
* Active or prior documented autoimmune or inflammatory disorders
* History of another primary malignancy, except for malignancy tre…
What they're measuring
1
Number of participants with Grade 3 or 4 possibly related adverse event (PRAE)
Timeframe: Within 6 months after the initiation of Investigational Medicinal Product (IMP)