Actively Recruiting
Adebrelimab With or Without SHR-8068 Combined With Cisplatin and Gemcitabine as First Treatment for Advanced Biliary Tract Cancer: A Randomized, Open-label Phase II Study
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-01-27
80
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining SHR-8068 and Adebrelimab with Cisplatin plus Gemcitabine, compared to Adebrelimab with Cisplatin plus Gemcitabine alone, as a first treatment for patients with advanced biliary tract cancer. This phase II, randomized, open-label, multicenter study focuses on patients aged 18 to 75 years with unresectable or metastatic biliary tract adenocarcinoma who have not received prior systemic anti-tumor therapy. Participants will receive study drugs including SHR-8068, Adebrelimab, Cisplatin, and Gemcitabine. The treatments are administered in combination as first-line therapy. The study compares the combination of SHR-8068 plus Adebrelimab and Cisplatin/Gemcitabine versus Adebrelimab plus Cisplatin/Gemcitabine alone. The trial is designed to assess these treatment regimens during the initial therapy phase. During the study, patients will be monitored for their tumor response using RECIST v1.1 criteria, with the primary outcome being the objective response rate from randomization until disease progression or new anti-tumor therapy initiation, up to about 14 months. Safety, organ function, and survival expectancy will also be tracked. Participants will have measurable lesions and an ECOG performance status of 0-1, and they must consent to contraception and informed consent procedures.
CONDITIONS
Official Title
Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic biliary tract adenocarcinoma
- No prior systemic anti-tumor therapy received
- At least one measurable lesion per RECIST v1.1
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function
- Use of one medically approved contraceptive method
- Voluntary participation with signed informed consent
You will not qualify if you...
- History or presence of other solid tumors
- Liver tumor burden exceeding 50% of total liver volume
- History of previous hepatic encephalopathy
- Presence of biliary obstruction with risk of infection
- Major surgery within 4 weeks before randomization
- Any active or suspected autoimmune disorder
- Active pulmonary tuberculosis
- Known HIV infection or active hepatitis
- Untreated central nervous system metastases
- Clinically symptomatic pleural or peritoneal effusion
- Poorly controlled cardiac symptoms or disease
- Abnormal blood clotting or bleeding tendency
- Known allergy to Adalimumab, other monoclonal antibodies, or trial drugs
- Other factors potentially affecting study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xin Shi
Y
Yujiao Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here