Trials / Recruiting
RecruitingNCT05057052
Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis
A Phase II Study of Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis (CASTLE-03)
- Status
- Recruiting
- 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 Sintilimab plus regorafenib for patients with colorectal cancer liver metastasis in the 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 regorafenib showed increased ORR in advanced colorectal cancer. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus regorafenib in previously treated colorectal cancer liver metastasis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sintilimab | Sintilimab plus regorafenib will be initiated on day 14 after cryoablation. Sintilimab will be administered at 200 mg i.v. every 3 weeks. |
| DRUG | Regorafenib | Regorafenib will be initiated on day 14 after cryoablation. Regorafenib 80 mg was given orally once daily on days 1-21 of a 28-day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. |
| COMBINATION_PRODUCT | US/CT-guided Percutaneous Cryoablation | Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone |
Timeline
- Start date
- 2021-09-26
- Primary completion
- 2026-09-25
- Completion
- 2026-09-25
- First posted
- 2021-09-27
- Last updated
- 2025-02-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05057052. Inclusion in this directory is not an endorsement.