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Brief Title: Cryoablation Combined With Sintilimab Plus Lenvatinib In Previously Treated Unresectable Liver Metastasis From Solid Tumors
Official Title: A Phase II Study of Cryoablation Combined With Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis From Solid Tumors (CASTLE-04)
Study ID: NCT05098847
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.
Detailed Description: Recent studies have suggested that local destruction of tumor tissue by cryoablation induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. While pd-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. And combination of pd-1 blocking antibody plus lenvatinib showed increased ORR in many type of solid tumors. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in previously treated unresectable liver metastasis from solid tumors.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Name: Peng Wang, MD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR