NCT07446465Not yet recruitingPhase 4
FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer
Exploratory Clinical Study of FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 24 Feb 2026
- Start date
- Mar 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Ye Xu
- Diseases
- Colorectal cancer
- NCT number
- NCT07446465
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 42
- From Mar 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior immune checkpoint inhibitor therapy;
- Recent major surgery;
Other illness
- Uncontrolled cardiovascular disease or hypertension;
- Active autoimmune disease requiring systemic therapy;
- Active infection including tuberculosis;
- Any condition deemed by investigators to compromise safety or study compliance.
Other
- CNS or leptomeningeal metastases;
- Pregnancy or lactation;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.