RecruitingPhase 2NCT06543836

ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer

ctDNA-guided Treatment of an Anti-angiogenic TKI Combined With a PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer Failed With Standard Therapy: a Randomized Controlled Phase 2 Clinical Trial


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

68 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The efficacy of combining TKI with PD-1 inhibitor in the treatment of advanced MSS/pMMR colorectal cancer with low levels of maxVAF in peripheral blood ctDNA failed with standard treatment was assessed, compared to standard treatment as chosen by researchers.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study uses a blood test called ctDNA (circulating tumor DNA) to guide treatment decisions for people with advanced colorectal cancer that doesn't respond well to immunotherapy on its own. It tests a combination of a targeted drug (a TKI) plus an immunotherapy (anti-PD-1) for this specific cancer type. **You may be eligible if...** - You are 18–80 years old with confirmed advanced or recurrent colorectal cancer - Your tumor is classified as pMMR or MSS (meaning standard immunotherapy alone is unlikely to work) - Your ctDNA level in the blood is below a certain threshold - Your cancer has progressed after standard chemotherapy regimens - You are in good physical condition (ECOG 0–1) **You may NOT be eligible if...** - Your cancer is classified as dMMR or MSI-H - You have had recent systemic therapy within 28 days - You have uncontrolled infections or serious organ problems - You have active autoimmune disease 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

DRUGSintilimab

Sintilimab 200mg, d1, with a treatment cycle of 21 days, and efficacy assessment every 2 cycles.

DRUGFruquintinib or Regorafenib

The treatment regimen consists of the following options: Option 1: Fruquintinib 5mg Qd, d1-21, Q4w, and efficacy assessment every 1.5 months. Option 2: Regorafenib 160mg Qd, d1-21, Q4w, and efficacy assessment every 1.5 months.

DRUGFruquintinib

Fruquintinib 5mg Qd, d1-14, with a treatment cycle of 21 days, and efficacy assessment every 2 cycles.


Locations(1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06543836


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