NCT06456515

Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC

A Single-Arm, Multicenter Phase II Clinical Study of Regorafenib and Sintilimab in Combination with Electroacupuncture in Patients with MSS Advanced Colorectal Cancer Who Have Failed More Than Second-Line Standard Chemotherapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First People's Hospital of Changzhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to find out whether Regorafenib and Sintilimab in combination with electroacupuncture works in treating participants with microsatellite stable (MSS) advanced colorectal cancer who have failed one or more second-line standard chemotherapy regimens. It will also learn about the efficacy and safety of the combination therapy. The main questions the trial aims to answer are: Does combination therapy reduce the overall survival time ? What medical problems do people have when they take combination therapy? Participants will Regorafenib, take for 2 weeks and stop for 1 week; Sintilimab, intravenous, every 3 weeks; Electroacupuncture was performed 1 day before, on the day of, and on the 2nd day after each cycle of Sintilimab administration, and patients completed 3 treatments in week 1, followed by 1 treatment per week for 2 weeks, with 5 treatments per dosing

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Regorafenib and Sintilimab in combination with electroacupuncture	Regorafenib, take for 2 weeks and stop for 1 week; Sintilimab, intravenous, every 3 weeks; Electroacupuncture was performed 1 day before, on the day of, and on the 2nd day after each cycle of Sintilimab administration, and patients completed 3 treatments in week 1, followed by 1 treatment per week for 2 weeks, with 5 treatments per dosing cycle.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-06-13
• Last updated: 2025-02-17

Locations

1 site across 1 country: China