Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC

Launched by BEIJING 302 HOSPITAL · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with liver cancer, specifically hepatocellular carcinoma (HCC), who are at high risk of their cancer coming back after surgery. The trial is comparing two options: one group will receive a combination of a medication called tislelizumab and a tyrosine kinase inhibitor (TKI) to help prevent the cancer from returning, while the other group will simply be monitored closely without additional treatment. The goal is to see if the combination therapy can reduce the chances of the cancer returning compared to just keeping an eye on the patients.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with HCC, which must be confirmed through medical tests. They should have undergone a procedure to remove or destroy the cancer with no remaining signs of it on follow-up imaging. Those at higher risk for recurrence may have larger tumors or multiple tumors, certain laboratory findings, or a personal or family history of cancer. Participants can expect regular check-ups to monitor their health, and the trial is currently recruiting patients. It's important to know that individuals with other serious health conditions or previous cancer treatments may not be able to join this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria:
• • solitary tumor \>2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm； poor tumor differentiation； macrovascular invasion of the portal vein(Vp1/Vp2) ； the absence or infiltration of a tumor capsule ； AFP≥32ng/ml； HBV DNA ≥105IU/ml； history of recurrence after curative treatment； family history of tumors.
• Exclusion Criteria:
• • Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;