Adjuvant Sintilimab and Bevacizumab Biosimilar Treatment After Surgery for Ruptured Liver Cancer Hepatocellular Carcinoma

What this Trial Is About

Researchers are studying patients with hepatocellular carcinoma HCC who have experienced spontaneous tumor rupture with hemorrhage. This condition has a high risk of death and recurrence after surgery, especially in Asian populations. The study evaluates the use of a combination of two drugs, sintilimab and a bevacizumab biosimilar, as additional treatment after surgical removal of the tumor. This is a Phase II, single-arm study aiming to find out if this treatment is tolerable and may improve outcomes for these high-risk patients. Participants will receive sintilimab 200 mg and bevacizumab biosimilar 15 mgkg intravenously on day 1 every three weeks. Treatment will continue after surgery for up to three years. The study focuses on patients who have undergone complete tumor removal, have good liver function, and no remaining visible cancer. The combination therapy is given as an adjuvant treatment to potentially delay or prevent cancer recurrence. During the study, participants will be monitored regularly for disease-free survival, overall survival, and any side effects using standard criteria. Imaging and laboratory tests will be done to check for liver cancer recurrence or spread within and outside the liver. The study will last up to three years, with ongoing assessments to track the timing and proportion of cancer recurrence or metastasis. Safety and tolerability of the treatment will also be closely observed throughout the study period.

Sintilimab Combined With Bevacizumab Biosimilar as Adjuvant Treatment After Resection of Ruptured Hepatocellular Carcinoma (CLEAR-2)