Actively Recruiting
Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin as First-line Treatment for Unresectable Biliary Tract Carcinoma A Prospective Single Arm Study
Led by Henan Cancer Hospital · Updated on 2024-12-27
63
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new combination treatment for people with unresectable biliary tract carcinoma (BTC), including advanced or metastatic cholangiocarcinoma and gallbladder carcinoma. This Phase 2 study aims to improve the first-line treatment of advanced BTC in China by adding anti-angiogenic drugs to a regimen of PD-L1 inhibitor adebrelimab combined with gemcitabine and cisplatin chemotherapy. The study will treat participants with adebrelimab given at 1200 mg every 3 weeks, apatinib at 250 mg daily, and chemotherapy with cisplatin (25 mg/m2) and gemcitabine (1000 mg/m2) on days 1 and 8 of a 3-week cycle. This combination is given as first-line treatment for unresectable BTC. The study is a single-arm design, meaning all participants receive this combination without a comparison group. Participants will be followed from the first dose until disease progression or death, with progression-free survival as the main outcome measured up to about 6 months after the last participant enrolls. During the study, researchers will monitor clinical status, tumor response, organ function, blood tests, and safety. Participants are expected to have adequate organ function and meet specific health criteria before joining, with ongoing follow-up to track treatment effects and adverse events.
CONDITIONS
Official Title
Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old, any gender
- Histologically confirmed, unresectable advanced or metastatic biliary tract carcinoma including intrahepatic or extrahepatic cholangiocarcinoma, or gallbladder carcinoma
- No prior systemic treatment for biliary tract carcinoma
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Normal function of main organs with specific blood counts and liver/kidney test limits
- Women of childbearing age must have a negative pregnancy test within 14 days before enrollment and agree to use contraception during and for 8 weeks after treatment; men must agree to contraception during and for 8 weeks after treatment
- Voluntary informed consent and agreement to cooperate with follow-up
You will not qualify if you...
- Diagnosis of neuroendocrine carcinoma
- Allergy to adebrelimab, apatinib, gemcitabine, cisplatin, or their ingredients
- Prior systemic treatment for biliary tract carcinoma
- Symptomatic pleural, pericardial effusion or ascites requiring frequent drainage
- History of organ transplantation including bone marrow or stem cell transplantation
- Active or uncontrolled serious infections including high fever before treatment
- Liver cirrhosis or active hepatitis B or C infection beyond normal limits
- History of psychotropic drug abuse or mental disorders
- Other malignancies within 5 years needing active treatment (except certain skin or in situ cancers with good prognosis)
- Uncorrectable blood clotting disorders
- Severe liver, kidney, lung diseases, uncontrollable diabetes, or other systemic diseases
- Tumor invading major blood vessels with high risk of fatal bleeding
- Active autoimmune disease or immunodeficiency except controlled hypothyroidism or type 1 diabetes
- Use of immunosuppressive or systemic steroid therapy within 14 days before consent
- Recent arterial or venous thrombosis events within 6 months
- Digestive diseases affecting drug absorption or causing bleeding/perforation
- Uncontrolled hypertension despite medication
- Surgery within 28 days before enrollment or unhealed surgical wounds
- Participation in other experimental drug studies within 4 weeks
- Pregnancy or breastfeeding
- Any condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
HeNan
Zhengzhou, China
Actively Recruiting
Research Team
Y
Ying Liu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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