Cryoablation with Cadonilimab and Bevacizumab for Liver Cancer with Lung Metastases

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

This study is testing if a new treatment that combines freezing liver tumors with two immunotherapy drugs can help patients with advanced liver cancer that has spread to the lungs feel better when other treatments haven't worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Lenvatinib, Cardonilizumab, Bevacizumab, atezolizumab, Cadonilimab
• Locations: 2 sites (Guanzhou, Guangdong and 1 other locations)
• Trial ID: NCT06265350 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with primary or recurrent hepatocellular carcinoma and specific pulmonary metastasis characteristics who have failed first-line systemic therapy.

Not a fit: Patients with other malignancies or those under 18 years old will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced liver cancer and lung metastases.

How similar studies have performed: Other studies have shown promising results with similar combinations of cryoablation and immunotherapy, indicating potential for success in this novel approach.

Eligibility criteria

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 this trial is running

Guanzhou, Guangdong and 1 other locations

• 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

Conditions Hepatocellular Carcinoma; Liver Cancer Stage IV; Pulmonary Metastases; Cadonilimab; Bevacizumab; Cryoablation