Active — Not RecruitingPhase 3

Camrelizumab, Apatinib Plus HAIC Versus Camrelizumab and Apatinib for HCC With Portal Vein Invasion: a Randomized Trial

China214 participantsStarted 2022-01-17

Plain-language summary

Compare the efficacy and safety of camrelizumab, apatinib plus FOLFOX-HAIC and camrelizumab plus apatinib in hepatocellular carcinoma with portal vein invasion.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. volunteered with written inform consent
✓. unresectable HCC or progression after surgery or locoregional threapy, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases practice guidelines and the China liver cancer (CNLC) guidelines
✓. Patients with portal vein tumor thrombosis (PVTT) confirmed by 2 kinds of imaging examinations
✓. no previous systemic therapy for HCC. Herbs, Chinese medicines or proprietary Chinese medicines that contain anti-cancer active ingredients in the instructions are allowed, but such treatments need to be terminated before randomization
✓. at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
✓. patients who had previously received local treatments (such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, trans-arterial chemoembolization, trans-arterial embolization, etc.)were allowed to be enrolled, but it was required that the target lesions were with no previous local treatment, or the target lesion had received local treatment but had progression according to the RECIST v1.1
✓. an Eastern Cooperative Oncology Group performance status of 0 to 1
✓. Child-Pugh A class liver function

Exclusion criteria

✕. intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma diagnosised by pathology
✕. patients with other malignant tumors except HCC within 5 years or at the same time, except for cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.
✕. patients who are planning to undergo or have previously received organ or allogeneic bone marrow transplantation
✕. history of hepatic encephalopathy
✕. moderate and severe ascites with clinical symptoms and uncontrolled pleural effusion and pericardial effusion
✕. a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within 6 months before the start of the study treatment
✕. a history of abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of study treatment
✕. a known hereditary or acquired bleeding (such as coagulopathy) or thrombotic tendency

What they're measuring

Overall survival

Timeframe: 2 months

Trial details

NCT IDNCT05198609

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

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