Actively Recruiting
A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-11-28
38
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)
CONDITIONS
Official Title
A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and signed the consent form
- Male or female aged 18 to 75 years at the time of consent
- Histologically or cytologically confirmed intrahepatic cholangiocarcinoma (ICC)
- Unresectable disease or progression after prior surgery or local treatment
- No prior systemic treatment for advanced ICC, except relapse more than 6 months after adjuvant chemotherapy post-surgery
- Completed any local regional therapy at least 4 weeks before baseline imaging with resolved toxicity (except alopecia) to grade 1 or less
- At least one measurable lesion according to RECIST v1.1 criteria
- Child-Pugh class A liver function
- ECOG performance status score of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function without severe dysfunction or immunodeficiency
- If active hepatitis B infection, viral DNA below specified levels and willing to receive antiviral therapy
- Women of childbearing potential must use reliable contraception or abstain and have a negative pregnancy test before treatment
- Men with partners of childbearing potential must use reliable contraception or abstain and agree not to donate sperm during the study period
You will not qualify if you...
- Known hepatocellular carcinoma or combined hepatocellular and intrahepatic cholangiocarcinoma
- Other active malignant tumors within 5 years or simultaneously, except certain localized cancers
- Planned or previous organ or allogenic bone marrow transplantation
- Treatment with other investigational products within 28 days before study treatment
- Prior treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, or CTLA-4
- Moderate-to-severe ascites requiring drainage or high Child-Pugh score; uncontrolled pleural or pericardial effusion
- Recent gastrointestinal bleeding within 6 months or history of abdominal fistula or perforation
- Known bleeding or clotting disorders, recent use of full-dose anticoagulants or certain antiplatelet drugs
- Thrombosis or thromboembolic events within 6 months prior to treatment
- Uncontrolled cardiac disease or hypertension
- Major vascular disease or recent major surgery within 4 weeks
- Unexplained intraperitoneal pneumatosis
- Metastasis to central nervous system or involvement of major airways or vessels
- History of hepatic encephalopathy or certain pulmonary diseases including active pneumonia or tuberculosis
- Active or history of autoimmune diseases that may relapse, except certain controlled conditions
- Recent use of immunosuppressive medications or systemic corticosteroids
- Known hypersensitivity to study drugs
- Severe infection or immunodeficiency within specified timeframes
- Hepatitis B and C co-infection
- Recent live attenuated vaccination or expected vaccination during treatment
- Other factors affecting study results or safety such as alcoholism, drug abuse, serious diseases, or social factors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
C
Changzhen Shang, M.D, PhD
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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