Actively Recruiting
Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma
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
This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine/cisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
HeNan
Zhengzhou, China
Actively Recruiting
Research Team
Y
Ying Liu, MD
CONTACT
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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