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Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC

Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First-Line Treatment for Advanced Hepatocellular Carcinoma (HCC): A Randomized, Controlled, Open-Label, Multicenter Phase III.

NCT07267806•Linhui Peng

View on ClinicalTrials.gov

Summary

This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients volunteered to participate in this study and signed informed consent;
•2. ≥18 years old, male and female;
•3. Before treatment, it was confirmed by histopathology or cytology, or clinically diagnosed as hepatomegaly.Patients with Hepatocellular Carcinoma, HCC);
•4. BCLC stage B or C hepatocellular carcinoma, which is not suitable for curative surgical or local therapies, or has progressed after such treatments.
•5. Local therapy (including but not limited to surgery, radiation therapy, transarterial chemoembolization \[TACE\], hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks prior to the baseline radiographic scan (with the exception of palliative radiotherapy, for which a 2-week interval is sufficient)."
•6. Has not received any systemic treatment for HCC.
•7. According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
•8. Child-pugh liver function grading: Grade A or Grade Better B (≤7 points)
•9. ECOG PS score 0-2;
•10. Expected survival ≥ 12 weeks;
+8 more criteria

Exclusion Criteria

•1. Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar carcinoma; having other active malignancies within the past 5 years or simultaneously, excluding HCC. Successfully treated localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.
•2. Patients who are preparing for or have previously undergone organ or allogeneic hematopoietic stem cell transplantation;
•3. Patients with clinical symptoms of moderate to severe ascites that require therapeutic puncture or drainage; uncontrolled pleural effusion or pericardial effusion of moderate amount or more;
•4. Patients with a history of gastrointestinal bleeding within 6 months before the start of the study treatment or a clear tendency for gastrointestinal bleeding, such as: high-risk or severe esophageal and gastric varices, localized active gastrointestinal ulcer lesions, or persistent positive fecal occult blood;
•5. Patients who have had abdominal fistulas, gastrointestinal perforation, or intra-abdominal abscesses within 6 months before the start of the study treatment;
•6. Patients with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombophilia.
•7. Currently using or having recently used (within 10 days before the start of the study treatment) aspirin \[\>325 mg/day (maximum antiplatelet dose)\] or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
•8. Occurrence of thrombotic or embolic events within 6 months before the start of the study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary .embolism).
•9. Uncontrolled cardiac clinical symptoms or conditions, such as:
•1. Heart failure of NYHA class II or above;
+23 more criteria

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

October 31, 2025

Primary Completion Date

October 1, 2029

Completion Date

October 1, 2032

Last Updated

December 16, 2025

Enrollment

326

ESTIMATED participants

Conditions

Hepato Cellular Carcinoma (HCC)Chemotherapy Effect

Interventions

Infusional mFOLFOX7 plus Camrelizumab and apatinib

DRUG

Camrelizumab and apatinib

DRUG

Contacts

Linhui Peng

CONTACT

8613710591214 penglinhui2927@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC

Inclusion Criteria

Exclusion Criteria

HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)

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