FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy f… (NCT07446465) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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.