RecruitingPhase 2NCT05954429

A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study


Sponsor

Fudan University

Enrollment

50 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this clinical trial is to learn about efficacy of fruquintinib combined with serplulimab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main purpose is to explore efficacy, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including ctDNA, TPS, CPS, tumor mutation burden, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, etc.) and the efficacy and drug resistance mechanism will be analyzed, which could provide reference for determining the advantaged group.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — fruquintinib (a targeted therapy) and serplulimab (an immunotherapy) — as a third-line treatment for people with advanced colorectal cancer that has spread to multiple sites beyond just the liver. This is for patients whose cancer has stopped responding to two prior standard treatment regimens. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic colorectal cancer - Your cancer has spread to sites other than just the liver (e.g., lungs, peritoneum) - Your cancer is classified as microsatellite stable (MSS or MSI-L) or mismatch repair proficient (pMMR) - You have received and progressed on two prior lines of standard chemotherapy - Your overall health (ECOG 0-2) and organ function are adequate **You may NOT be eligible if...** - Your cancer is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) - You have previously received PD-1, PD-L1, or CTLA-4 immunotherapy - You have active autoimmune disease or a history of serious immune-related complications - You are HIV positive or have active hepatitis B or C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGserplulimab

Serplulimab is an innovative monoclonal antibody targeting PD-1, developed by Shanghai Henlius Biotech, Inc. 300 mg, q3w Other name: HLX10

DRUGFruquintinib

5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity.


Locations(2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05954429


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