SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-l… (NCT06465563) | Clinical Trial Compass
Active — Not RecruitingPhase 2
SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer
China93 participantsStarted 2024-07-01
Plain-language summary
Cohort A and B: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in combination with Cisplatin plus Gemcitabine (CisGem), compared with Adebrelimab in combination with CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer. Cohort C: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab and Bevacizumab in combination with Cisplatin Plus Gemcitabine (CisGem) as first-line treatment in patients with Advanced Biliary Tract cancer.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18\~75 years old, both male and female;
. Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma);
. Has not received prior systemic anti-tumor therapy;
. At least one measurable lesion based on RECIST v1.1 criteria;
. ECOG PS score: 0-1 points;
. Expected survival period ≥ 3 months;
. Adequate organ function;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial combining four agents — SHR-8068, adebrelimab, bevacizumab, and platinum-based chemotherapy — what is your best understanding of the safety profile of this combination, and are there any side effects I should be particularly watchful for given my overall health?
2The trial is no longer actively recruiting, so enrollment is closed — but based on what's being studied here, does this four-drug combination approach reflect where treatment for advanced biliary tract cancer is heading, and should it influence the regimen we consider for me?
3The main thing this trial is measuring is Objective Response Rate — meaning how many patients' tumors shrink — so once results are available, how would a response rate from a Phase 2 study like this change your recommendation for my treatment plan?
4Is platinum-based chemotherapy already part of the standard first-line treatment for my specific type of biliary tract cancer, and how does adding SHR-8068 and adebrelimab to that backbone compare to what I could receive outside of a trial right now?
5Are there other active trials or recently approved options for advanced biliary tract cancer that I should be weighing alongside what this trial is investigating, especially if my cancer has any specific genetic or molecular features?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)