Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases
Recruiting · NCT06265350 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- under 18 years or over 75 years;
- metastases \>10
- non-lung metastases;
- incomplete clinical data;
- metastases diameter \> 5 cm;
- intrahepatic tumors \> 5, and tumor burden \> 1/2 liver volume;
- PVTT type Vp 4;
- lost to follow-up within 3 months.
Where it is running
2 locations listed.
- Sun Yat-sen University Cancer Center - Guanzhou, Guangdong, China
- Sun Yat-sen University Cancer Center - Guanzhou, Guangdong, China