Clinical trial · Interventional
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
NCT06265350CI-TRIAL-00074153recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bevacizumab | — | UNRESOLVED | — |
| Cadonilimab | — | UNRESOLVED | — |
| Cryoablation | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer Stage IV | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Pulmonary Metastases | Liver Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cadonilimab | Drug | — | UNRESOLVED |
| Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bevacizumab+Cadonilimab group
- description
- Patients accepted Bevacizumab (7.5mg/kg，Q3W， IV) plus Cadonilimab (375mg，Q3W， IV)
- interventionNames
- Drug: Cadonilimab
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Cryoablation+Bevacizumab+Cadonilimab
- description
- Patients accepted Cryoablation of pulmanary metastases combined with Bevacizumab (7.5mg/kg，Q3W， IV) and Cadonilimab (375mg，Q3W， IV)
- interventionNames
- Drug: Cadonilimab
- Drug: Bevacizumab
- Procedure: Cryoablation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.