Actively Recruiting
TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma
Led by Guohui Xu · Updated on 2026-04-14
101
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC. The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC. This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.
CONDITIONS
Official Title
TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically or clinically confirmed hepatocellular carcinoma
- Age between 18 and 80 years old
- Performance status of 0 or 1 on the ECOG scale
- Barcelona clinical liver cancer (BCLC) stage B or C
- Initial treatment for hepatocellular carcinoma
- At least one measurable lesion according to mRECIST criteria
- Child Pugh score of 7 or less
- Sufficient organ and bone marrow function
- Expected survival time of at least 12 weeks
- Effective contraceptive measures for women of childbearing age and male patients with partners of childbearing age during treatment and for 6 months after last medication
- Signed written informed consent and ability to comply with study visits and procedures
You will not qualify if you...
- Fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma, or other histologically confirmed components
- History of hepatic encephalopathy or liver transplantation
- Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage
- Tumor burden greater than 70%, diffuse liver cancer, or tumors unsuitable for mRECIST evaluation
- Prior local treatment (ablation, TACE), surgery, or radiotherapy for liver cancer before first administration
- Previous systemic chemotherapy, targeted therapy, or immunotherapy
- Severe blood cell count decreases or coagulation dysfunction not correctable
- Active hepatitis B or C infection with specified viral load thresholds
- Central nervous system metastasis
- Recent or severe esophageal or gastric varices or high bleeding risk
- History of recent serious thromboembolism events
- Tumor thrombus involving main portal vein or superior mesenteric vein
- Recent use of aspirin or other platelet-inhibiting drugs
- Uncontrolled hypertension or history of hypertensive crisis
- Symptomatic heart failure or serious arrhythmias
- Serious bleeding disorders or ongoing thrombolysis
- Recent gastrointestinal perforation, fistula, obstruction, or chronic intestinal diseases
- History of serious lung diseases or impairment
- Active or recent tuberculosis treatment
- HIV or syphilis infection with poor control
- Recent severe infections requiring hospitalization
- Active autoimmune diseases requiring systemic treatment within past 2 years
- Recent use of immunosuppressive drugs except limited glucocorticoids
- Recent live attenuated vaccine use
- Recent major surgery or unhealed wounds
- Uncontrolled metabolic or systemic diseases increasing medical risk
- Allergy to any PD-1 monoclonal antibody component
- Women of childbearing age unwilling or unable to use contraception during and after treatment
- Fertile males without effective contraception when partner is childbearing age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xuegang Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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