RECRUITINGINTERVENTIONAL
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
About This Trial
This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Cadonilimab
Cadonilimab, 375mg,Q3W, IV
DRUG
Bevacizumab
Bevacizumab, 7.5mg/kg,Q3W, IV
PROCEDURE
Cryoablation
Patients accepted Cryoablation of pulmanary metastases
Locations (2)
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China