Actively Recruiting
Efficacy and Safety of Apatinib Combined With Adebrelimab and GEMOX Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma (ICC)
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-11-28
38
Participants Needed
1
Research Sites
69 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
Researchers are evaluating the effectiveness and safety of a new combination treatment for patients with advanced, unresectable intrahepatic cholangiocarcinoma (ICC). This study aims to improve outcomes by combining apatinib, an oral drug targeting VEGFR2, with adebrelimab, an immune checkpoint inhibitor, plus GEMOX chemotherapy. The main goal is to increase the tumor response rate, building on historical data where chemotherapy alone had a 16% response rate, aiming instead for 40%. Secondary goals include measuring progression-free survival, overall survival, and monitoring side effects, while exploring biological markers that might predict better responses. Participants will receive a combination therapy including adebrelimab given intravenously every three weeks at 1200 mg, apatinib taken orally daily at 250 mg, and up to six cycles of GEMOX chemotherapy in 21-day cycles. The combination treatment will continue for up to two years or until the cancer worsens or side effects become unmanageable. This trial is a single-arm, multicenter phase II study involving 38 patients across multiple hospitals. During the trial, participants will be closely monitored for tumor response over 12 months, side effects from the first drug dose to 30 days after the last adebrelimab dose, and survival outcomes up to 24 months. Assessments will include imaging to measure tumor size, evaluation of adverse events, and tracking of progression-free and overall survival. The study will also assess biological markers to understand treatment response better, with ongoing safety evaluations throughout the study duration.
CONDITIONS
Brief 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 consent
- Histologically or cytologically confirmed intrahepatic cholangiocarcinoma (ICC)
- Not a candidate for surgery or disease progressed after surgery/local treatment
- No prior systemic treatment for advanced ICC, except relapse >6 months after adjuvant chemotherapy
- Completed local regional therapy at least 4 weeks before baseline scan with resolved toxicity (except alopecia)
- At least one measurable lesion by RECIST v1.1 criteria
- Child-Pugh class A liver function
- ECOG performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function without severe dysfunction or immunodeficiency
- If active hepatitis B, viral DNA must be below specified levels and antiviral therapy given
- Women of childbearing potential must use reliable contraception and have negative pregnancy test
- Men with partners of childbearing potential must use contraception and avoid sperm donation during study period
You will not qualify if you...
- Known hepatocellular carcinoma or other liver cancers besides ICC
- Other active cancers within 5 years except certain cured localized tumors
- Planning or prior organ or bone marrow transplantation
- Treatment with other investigational products within 28 days before study
- Prior treatment with immune checkpoint inhibitors
- Moderate-to-severe symptomatic ascites or pleural/pericardial effusion
- Recent gastrointestinal bleeding or abdominal fistula within 6 months
- Known bleeding disorders or recent use of full-dose anticoagulants
- Recent use of high-dose antiplatelet drugs
- Recent thrombosis or thromboembolic events within 6 months
- Uncontrolled cardiac disease or hypertension
- Major vascular disease or recent major surgery
- Unexplained intraperitoneal pneumatosis
- Metastasis to central nervous system or critical vascular invasion
- History of hepatic encephalopathy or active serious lung diseases
- Active or history of autoimmune disease that may relapse
- Use of immunosuppressive medication or corticosteroids above specified doses
- Known hypersensitivity to study drugs
- Severe infection within 4 weeks before study
- Congenital or acquired immunodeficiency including HIV
- Hepatitis B and C co-infection
- Recent live attenuated vaccine administration
- Other factors affecting safety or study results as judged by investigators
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or intolerable side effects
Participants receive a combination of Adebrelimab (IV every 3 weeks), apatinib (oral daily), and GEMOX chemotherapy (up to 6 cycles in 21-day cycles). Apatinib and Adebrelimab are continued until cancer progression, intolerable side effects, or up to two years.
Visits every 3 weeks for drug administration during treatment cycles
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
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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