Actively Recruiting
Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases: A Single-center, Prospective, Randomized Controlled Phase II Study
Led by Sun Yat-sen University · Updated on 2024-02-20
80
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining cryoablation with Cadonilimab and Bevacizumab in treating people with hepatocellular carcinoma (HCC) that has spread to the lungs. HCC commonly metastasizes to the lungs, and while standard treatments focus on systemic therapy, this study explores adding cryoablation, which freezes tumors to kill cancer cells and stimulate immune responses, potentially enhancing treatment outcomes. Cadonilimab is a bispecific antibody targeting immune checkpoints, and Bevacizumab targets blood vessel growth factors that may suppress immune attack on tumors. Participants receive one of two treatment plans: either Bevacizumab plus Cadonilimab intravenously every three weeks, or cryoablation of lung metastases combined with the same drug regimen. Cryoablation aims to destroy lung tumors directly while the drugs work systemically to control cancer. The study is randomized and open-label, comparing these approaches to evaluate response rates and survival. During the study, participants will be monitored for tumor response, progression-free survival at six months, and overall survival at 12 months. Evaluations include imaging scans and clinical assessments to measure tumor size and treatment effects. The study duration extends up to January 2027, with regular visits for drug administration and follow-up to assess safety and efficacy outcomes.
CONDITIONS
Brief Title
Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary or recurrent hepatocellular carcinoma (HCC)
- Synchronous or asynchronous pulmonary-only metastases, with 5 to 10 tumors
- Metastases diameter 5 cm or less
- Up to 5 intrahepatic tumors, with tumor burden no more than half of liver volume
- Portal vein tumor thrombus (PVTT) type Vp3 or lower
- Previous failure of first-line systemic therapy including tyrosine kinase inhibitors (TKI) like Sorafenib or Lenvatinib, with or without PD-1 or PD-L1 inhibitors
- Controlled intrahepatic tumors with no progression of pulmonary metastases as defined by partial or stable response
- May have received locoregional therapy such as TACE or HAIC
- Child-Pugh liver function class A or B
- Performance status (PS) 0 or 1
- No history of other malignancies
You will not qualify if you...
- Younger than 18 years or older than 75 years
- More than 10 metastases
- Metastases outside the lungs
- Incomplete clinical data
- Metastases larger than 5 cm in diameter
- More than 5 intrahepatic tumors or tumor burden greater than half of liver volume
- Portal vein tumor thrombus type Vp4
- Lost to follow-up within 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive cryoablation of pulmonary metastases combined with intravenous Cadonilimab and Bevacizumab every 3 weeks, or intravenous Cadonilimab and Bevacizumab every 3 weeks without cryoablation.
Infusions every 3 weeks with cryoablation procedure for the experimental group
Duration - Up to 6 to 12 months after treatment
Participants are monitored for progression-free and overall survival outcomes after treatment.
Approximately 3 to 4 visits for monitoring
Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China, 510000
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Q
Qunfang Zhou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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