RecruitingPhase 3

Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC

China262 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. Have received immunotherapeutic drugs or interferon in the past.
✕. Severe allergic reaction to other monoclonal antibodies, immunotherapy or chemotherapy.
✕

What they're measuring

6-mon PFSR

Timeframe: up to approximately 3 years

Hepatic Reserve Function Impairment Rate(ICG-15min)

Timeframe: up to approximately 3 years

Trial details

NCT IDNCT06172205

SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Yunxiuxiu Xu, MD

17722864609 xuyxx@mail.sysu.edu.cn

View on ClinicalTrials.gov More BCLC Stage C Hepatocellular Carcinoma trials