Not Yet RecruitingPhase 4

FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

China42 participantsStarted 2026-03-01

Plain-language summary

To evaluate the efficacy and safety of immune checkpoint inhibitor-based combination therapy with targeted therapy and chemotherapy in patients with locally advanced unresectable or metastatic colorectal cancer.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-75 years; * Histologically confirmed adenocarcinoma of colorectal cancer, initially unresectable locally advanced or metastatic/recurrent disease; * Expected survival ≥12 weeks; * No prior systemic antitumor therapy for colorectal cancer; * Confirmed pMMR by IHC or MSS/MSI-L by PCR or NGS; * ECOG PS 0-1; * At least one measurable lesion per RECIST v1.1; * Adequate organ and bone marrow function; * Controlled viral hepatitis status as specified; * Signed written informed consent. Exclusion Criteria: * Prior immune checkpoint inhibitor therapy; * CNS or leptomeningeal metastases; * Uncontrolled cardiovascular disease or hypertension; * Active autoimmune disease requiring systemic therapy; * Active infection including tuberculosis; * Recent major surgery; * Pregnancy or lactation; * Any condition deemed by investigators to compromise safety or study compliance.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Conversion Rate to Surgery

Timeframe: ≤ 6 months

Objective Response Rate

Timeframe: ≤6 month

Trial details

NCT IDNCT07446465

SponsorYe Xu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Ye Xu

+86 18017312565 yexu@shmu.edu.cn

View on ClinicalTrials.gov More Colorectal Cancer (Locally Advanced or Metastatic) trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.