Infusional FOLFOX Plus Camrelizumab and Apatinib Versus HAIC-FOLFOX Plus Camrelizumab and Apatinib for Hepatocellular Carcinoma of BCLC C Stage: A Multi-center Randomized Phase III Trial

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 intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75, male or female;

• The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to BCLC stage C.

• Child-pugh liver function grading: Grade A or B

• Did not received any type of other first-line drugs such as Sorafenib

• 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);

• ECOG PS score 0-2;

• Expected survival ≥ 12 weeks;

• The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days): Blood routine:White blood cells count ≥3.0×10\^9/L Platelet count ≥70×10\^9/L Hemoglobin ≥80g/L(without blood transfusion); Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN)

• Subjects with HBV or HCV infection should receive anti-virus treatment without interfron.

⁃ Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication;Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period.

⁃ Patients volunteered to participate in this study and signed informed consent; Subjects have good compliance and cooperate with the follow-up.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Yunxiuxiu Xu, MD
xuyxx@mail.sysu.edu.cn
17722864609
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 262
Treatments
Experimental: Infusional FOLFOX
Infusional mFOLFOX7 plus Camrelizumab and apatinib
Active_comparator: HAIC-FOLFOX
HAIC-FOLFOX plus Camrelizumab and apatinib
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov