Cryoablation with Cadonilimab and Bevacizumab for Liver Cancer with Lung Metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of combining cryoablation with the immunotherapy agents Cadonilimab and Bevacizumab in patients with advanced hepatocellular carcinoma (HCC) that has spread to the lungs. Cryoablation is a minimally invasive procedure that freezes tumors to destroy cancer cells and stimulate immune responses. The study aims to improve outcomes for patients who have not responded to standard systemic therapies. By targeting vascular endothelial growth factor (VEGF), the treatment seeks to enhance immune response and tumor control.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. primary or recurrent HCC;
2. synchronous metastases (within one month after diagnosing of HCC) or asynchronous metastases (more than one month after diagnosis of HCC);
3. pulmonary-only metastases \>5 and ≤10;
4. metastases diameter ≤ 5 cm;
5. intrahepatic tumors ≤5, and tumor burden ≤1/2 liver volume;
6. PVTT type Vp≤3;
7. 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;
8. 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);
9. locoregional therapy (including TACE or HAIC) were also included;
10. Child-Pugh class A or B;
11. PS 0 or 1;
12. no history of other malignancies.

Exclusion Criteria:

1. under 18 years or over 75 years;
2. metastases \>10
3. non-lung metastases;
4. incomplete clinical data;
5. metastases diameter \> 5 cm;
6. intrahepatic tumors \> 5, and tumor burden \> 1/2 liver volume;
7. PVTT type Vp 4;
8. lost to follow-up within 3 months.

Where it's running

• Sun Yat-sen University Cancer Center
  Guanzhou, Guangdong, China Recruiting
• Sun Yat-sen University Cancer Center
  Guanzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qunfang Zhou, MD
• Email: zhouqun988509@163.com
• Phone: 86 19868000115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.