RecruitingNot ApplicableNCT06265350

Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases

Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases: A Single-center, Prospective, Randomized Controlled Phase II Study

Sponsor

Sun Yat-sen University

Enrollment

80 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Pulmonary Metastases Liver Cancer Stage IV Cadonilimab Bevacizumab Cryoablation

Summary

This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

primary or recurrent HCC;
synchronous metastases (within one month after diagnosing of HCC) or asynchronous metastases (more than one month after diagnosis of HCC);
pulmonary-only metastases \>5 and ≤10;
metastases diameter ≤ 5 cm;
intrahepatic tumors ≤5, and tumor burden ≤1/2 liver volume;
PVTT type Vp≤3;
patients underwent first-line system therapy failure, the first-line system included tyrosine kinase inhibitor (TKI), such as Sorafenib or Lenvatinib, with or without PD-1 or PDL1 inhibitor;
the intrahepatic tumors were effectively controlled and pulmonary metastases were no progression, and the controlled intrahepatic tumors were defined as partial or stable response according to modified Response Evaluation Criteria in Solid Tumors (mRECIST);
locoregional therapy (including TACE or HAIC) were also included;
Child-Pugh class A or B;
PS 0 or 1;
no history of other malignancies.