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Clinical Trial 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.


Clinical Trial 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 Medication must be discontinued until disease progression, intolerable toxicity, informed consent is withdrawn, or investigator judgment is made.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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05894837
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Shanshan Weng
Phone +86-13758118823
Email 2310053@zju.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date June 1, 2023
Completion date June 1, 2025

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