NCT05098847 Cryoablation Combined with Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis from Solid Tumors
| NCT ID | NCT05098847 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Liver Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2021-10-29 |
| Primary Completion | 2025-10-30 |
Trial Parameters
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Brief Summary
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib for patients with unresectable liver metastasis, who had progressed after, or were refractory to first- or later-line therapy.
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained. * Age ≥ 18 years at time of study entry. * Participants must have unresectable liver metastasis from solid tumors. * Participants must have progressed after, or were refractory to first- or later-line therapy in the liver metastatic setting. * Participants who had received previous antiangiogenic or anti-epidermal growth factor receptor (EGFR) therapy were eligible. * At least one measurable site of disease as defined by RECIST criteria 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 (C