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RECRUITINGPHASE2

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)

NCT05057052•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent obtained.
•Age ≥ 18 years at time of study entry.
•Participants must have colorectal cancer liver metastasis.
•Participants must have failed at least two previous systemic chemotherapy regimens (containing fluorouracil, oxaliplatin, and irinotecan) 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 (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )
•Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
+1 more criteria

Exclusion Criteria

•History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
•Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
•Prior treatment with cryoablation.
•Prior treatment with regorafenib.
•RFA and resection administered less then 4 weeks prior to study treatment start.
•Radiotherapy administered less then 4 weeks prior to study treatment start.
•Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
•Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
•Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
•Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.
+17 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

September 26, 2021

Primary Completion Date

September 25, 2026

Completion Date

September 25, 2026

Last Updated

February 27, 2025

Enrollment

ESTIMATED participants

Conditions

Liver MetastasesColorectal Cancer Metastatic

Interventions

Sintilimab

DRUG

Regorafenib

DRUG

US/CT-guided Percutaneous Cryoablation

COMBINATION_PRODUCT

Contacts

Peng Wang, MD

CONTACT

86-21-64175590 peng_wang@fudan.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis

Inclusion Criteria

Exclusion Criteria

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