NCT06032845 Cryoablation Combined with Tislelizumab Plus Lenvatinib in Previously Treated Solid Tumors (CASTLE-11)
| NCT ID | NCT06032845 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2025-12-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus Lenvatinib for patients with previously treated solid tumors.
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained. * Age ≥ 18 years at time of study entry. * Participants must have solid tumors. * Participants must have failed from chemotherapy or other anti-cancer therapy or standard therapy was no longer feasible. * Participants who had received previous anti-angiogenesis or anti-PD1/PDL1 therapy were eligible. * At least one measurable site of disease as defined by RECIST v1.1 with spiral CT scan or MRI. * Performance status (PS) ≤ 2 (ECOG scale). * Life expectancy of at least 12 weeks. * Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥75 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula ) * Female patie