Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06491355
PHASE2

First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, multi-center, randomized controlled clinical intervention study, aiming to explore the effectiveness and safety of mfolfox6 and hlx04 regimens combined with slulimumab as first-line treatment for MSS-type initial unresectable metastatic colorectal cancer after induction therapy. This study plans to include a total of 72 patients with untreated MSS-type initial unresectable metastatic colorectal cancer. This study randomly allocated groups through a randomization system, and entered the following treatment groups at a ratio of 1:1: (1) Experimental group: mfolfox6 and hlx04 regimen induction therapy followed by slulimab treatment (36 cases); (2) Control group Group: mfolfox6 and hlx04 regimen treatment (36 cases).

Official title: Efficacy and Safety of First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer: A Prospective, Multicenter, Randomized, Controlled Trial (ASTRUM-IUmCRC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-07-01

Completion Date

2026-06-30

Last Updated

2024-07-09

Healthy Volunteers

No

Interventions

DRUG

mfolfox6 and hlx04 regimen and Serplulimab

mfolfox6 and hlx04 regimen induction therapy followed by combined treatment with slulimumab in the experimental arm. In the active comparator. only with mfolfox6 and hlx04 regimen treatment.

DRUG

mfolfox6 and hlx04 regimen

In the active comparator. only with mfolfox6 and hlx04 regimen treatment.

Locations (1)

Sir Run Run Shao hospital

Hanzhou, Zhejiang, China