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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

‣ Urine protein \<2 (if urine protein ≥2, a 24-hour urine protein quantification can be performed; 24-hour urine protein \<1.0 g is allowed for inclusion).

⁃ 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.

⁃ Women of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to study enrollment, must not be breastfeeding, and must agree to use contraception during the study and for 6 months after the study; men must agree to use contraception during the study and for 6 months after the study.

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Locations
Other Locations
China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Linhui Peng
penglinhui2927@qq.com
8613710591214
Time Frame
Start Date: 2025-10-31
Estimated Completion Date: 2032-10
Participants
Target number of participants: 326
Treatments
Experimental: Infusional FOLFOX
Infusional mFOLFOX7 plus Camrelizumab and apatinib
Active_comparator: Excluding FOLFOX
Camrelizumab and Apatinib
Related Therapeutic Areas
Sponsors
Leads: Linhui Peng

This content was sourced from clinicaltrials.gov

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