Trials / Unknown
UnknownNCT05893056
Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Gastric Cancer Liver Metastasis (CASTLE-09)
A Phase II Study to Evaluate the Efficacy and Safety of Cryoablation Combined With Tislelizumab Plus Lenvatinib in Previously Treated Gastric Cancer Liver Metastasis
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus Lenvatinib for patients with gastric cancer liver metastasis in the second-/third-Line setting.
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 types of human cancers. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus Lenvatinib in previously treated gastric cancer liver metastasis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cryoablation | Cryoablation is performed under US or CT guidance per Investigator decision. |
| DRUG | Tislelizumab | a PD-1 immune check inhibitor |
| DRUG | Lenvatinib | Lenvatinib capsules |
Timeline
- Start date
- 2023-06-16
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
- First posted
- 2023-06-07
- Last updated
- 2023-06-27
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05893056. Inclusion in this directory is not an endorsement.