Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC

NCT07267806 | Recruiting Phase 3

• 1 other identifier: SYSKY-2025-787-01
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepato Cellular Carcinoma (HCC); Chemotherapy Effect

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  The time from the start of treatment to the first progression of the patient's diseaseTime based on RECIST V1.1.

  up to approximately 3 years

• Overall Survival(OS)

  The time between the start of treatment and the patient's deathTime.

  up to approximately 5 years

Secondary Outcomes (17)

• Objective Response Rate(ORR)

  up to approximately 3 years

• During of response(DOR)

  up to approximately 3 years

• Disease control rate(DCR)

  up to approximately 3 years

• Time to progression(TTP)

  up to approximately 3 years.

• Progression-Free Survival based on mRECIST(mPFS)

  up to approximately 3 years

Study Arms (2)

Infusional FOLFOX

EXPERIMENTAL

Infusional mFOLFOX7 plus Camrelizumab and apatinib

Drug: Infusional mFOLFOX7 plus Camrelizumab and apatinib

Excluding FOLFOX

ACTIVE COMPARATOR

Camrelizumab and Apatinib

Drug: Camrelizumab and apatinib

Interventions

Camrelizumab and apatinib DRUG

Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.

Excluding FOLFOX

Infusional mFOLFOX7 plus Camrelizumab and apatinib DRUG

Oxaliplatin 85mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on Dand then 2400mg/m2 for 46h of each 21 day cycle. this chemotherapy regimen should be administered for a maximum of 6 cycles. Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.

Infusional FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients volunteered to participate in this study and signed informed consent;
• ≥18 years old, male and female;
• Before treatment, it was confirmed by histopathology or cytology, or clinically diagnosed as hepatomegaly.Patients with Hepatocellular Carcinoma, HCC);
• BCLC stage B or C hepatocellular carcinoma, which is not suitable for curative surgical or local therapies, or has progressed after such treatments.
• 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)."
• Has not received any systemic treatment for HCC.
• 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);
• Child-pugh liver function grading: Grade A or Grade Better B (≤7 points)
• ECOG PS score 0-2;
• Expected survival ≥ 12 weeks;
• Major organ functions are basically normal and meet the following requirements (within 7 days before starting the study treatment):
• Complete blood count: absolute neutrophil count ≥ 1.5\*10\^9/L, platelets (PLT) ≥ 75\*10\^9/L, hemoglobin ≥ 90 g/L;
• Blood biochemistry: albumin ≥ 25 g/L; total bilirubin ≤ 3.0 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 5 × ULN; creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCl) \> 50 mL/min.
• International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) no more than 6 seconds above the normal control range;
• Patients with active hepatitis B virus (HBV) infection must receive anti-HBV therapy prior to initiating study treatment and be willing to continue antiviral therapy throughout the study; hepatitis C virus (HCV) RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines with liver function not exceeding CTCAE grade 1 elevation.

You may not qualify if:

• 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.
• Patients who are preparing for or have previously undergone organ or allogeneic hematopoietic stem cell transplantation;
• 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;
• 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;
• Patients who have had abdominal fistulas, gastrointestinal perforation, or intra-abdominal abscesses within 6 months before the start of the study treatment;
• Patients with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombophilia.
• 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;
• 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).
• Uncontrolled cardiac clinical symptoms or conditions, such as:
• Heart failure of NYHA class II or above;
• Unstable angina;
• Myocardial infarction occurring within the past year;
• Clinically significant supraventricular or ventricular arrhythmias requiring medical intervention;
• Patients with hypertension whose condition is poorly controlled by medication and who are assessed by a doctor to be at high risk when using apatinib;
• Suffering from hypertension that cannot be well controlled with antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg); history of hypertensive crises or hypertensive encephalopathy;

Sponsors & Collaborators

• Linhui Peng: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; apatinib

Central Study Contacts

Linhui Peng

CONTACT

8613710591214; penglinhui2927@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: Arm1: infusional FOLFOX plus Camrelizumab and Apatinib Arm2: Camrelizumab and Apatinib

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2032
• Last Updated: December 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)