Actively Recruiting
Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-12-03
262
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center randomized phase III clinical study of first-line intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.
CONDITIONS
Official Title
Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Clinical diagnosis of primary hepatocellular carcinoma with BCLC stage C
- Child-Pugh liver function grade A or B
- No prior use of first-line drugs like Sorafenib
- At least one measurable lesion by RECIST 1.1 criteria on CT or MRI scan
- ECOG performance status score between 0 and 2
- Expected survival of 12 weeks or more
- Adequate vital organ function based on blood counts and liver/kidney tests
- HBV or HCV infected patients must be on antiviral treatment without interferon
- Women of childbearing age must agree to use contraception during and for 6 months after treatment; males must also agree to use contraception during and 6 months post-study
- Signed informed consent and willingness to comply with study procedures and follow-up
You will not qualify if you...
- Previous treatment with immunotherapy drugs or interferon
- Severe allergic reactions to monoclonal antibodies, immunotherapy, or chemotherapy
- Pregnant or breastfeeding women
- Congenital or acquired immune deficiency
- Abnormal blood clotting or bleeding disorders requiring treatment
- Other active cancers except cured skin basal cell carcinoma or cervical carcinoma in situ
- Active infections or fever within 7 days prior to study start
- Moderate to severe ascites or uncontrolled pleural or pericardial effusions
- History of significant gastrointestinal bleeding or bleeding risk within 6 months
- Recent abdominal fistula, gastrointestinal perforation, or abscess within 6 months
- Recent thrombotic or embolic events within 6 months
- Major vascular disease or recent severe wounds or ulcers
- Central nervous system metastases
- History of substance abuse or untreated mental disorders affecting study participation
- Any condition that may affect study results or patient safety as judged 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
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Yunxiuxiu Xu, 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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