Spots Global Cancer Trial Database for Serplulimab+Regorafenib +Hepatic Artery Bicarbonate Infusion in Patients With Colorectal Cancer and Liver Metastases

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Trial Identification

Brief Title: Serplulimab+Regorafenib +Hepatic Artery Bicarbonate Infusion in Patients With Colorectal Cancer and Liver Metastases

Official Title: Serplulimab in Combination With Regorafenib and Hepatic Artery Bicarbonate Infusion for Third-line Treatment in Patients With Colorectal Cancer and Liver Metastases: a Single-center, Single-arm, Phase 2 Trial

Study ID: NCT05894837

Conditions

Colorectal Cancer

Liver Metastases

Interventions

Serplulimab+Regorafenib

Hepatic Artery Bicarbonate Infusion

Study Description

Brief Summary: A single-center, single-arm, phase 2 trial of Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion for third-line treatment in patients with colorectal cancer and liver metastases. A total of 30 patients are planned to be enrolled.

Detailed Description: This is a single-center, single-arm, phase 2 trial. Enroll 30 patients with colorectal cancer and liver metastases and failure of standard therapy. Administer serplulimab intravenously(once every two weeks)in combination with regorafenib(from the first day to the 21th day) and hepatic artery bicarbonate infusion (once every four weeks). Medication must be discontinued until disease progression, intolerable toxicity, informed consent is withdrawn, or investigator judgment is made. The primary endpoint is objective response rate (ORR), and secondary endpoints are progression-free survival (PFS), overall survival (OS), and adverse effects (AE).