About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Infusional mFOLFOX7 plus Camrelizumab and apatinib
  • Camrelizumab and apatinib

Treatment groups

326 Participants
are divided into 2 treatment groups

Locations

1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University510000, GuangzhouGuangdong, China

Sponsors and collaborators

Linhui Peng

Lead sponsor

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

Sponsor institution