Clinical trial · Interventional
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
NCT07446465CI-TRIAL-00104401not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (Locally Advanced or Metastatic) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Microsatellite Stable (MSS) | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fruquintinib | Drug | Fruquintinib | ALIAS |
| mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) | Drug | — | UNRESOLVED |
| Serplulimab | Drug | Serplulimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Conversion Therapy
- description
- Conversion Therapy (≤6 months) Fruquintinib: 4 mg orally once daily, Days 1-21, every 4 weeks mFOLFOX6: Oxaliplatin 85 mg/m² IV q2w Leucovorin 400 mg/m² IV q2w 5-FU 400 mg/m² IV bolus Day 1 5-FU 1200 mg/m²/day continuous IV infusion Days 2-3 Serplulimab: 200 mg IV Day 1, q2w Fruquintinib must be stopped ≥2 weeks prior to surgery and resumed ≥4 weeks postoperatively.
- interventionNames
- Drug: Serplulimab
- Drug: Fruquintinib
- Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Primary outcomes (2)
- measure
- Conversion Rate to Surgery
- timeFrame
- ≤ 6 months
- measure
- Objective Response Rate
- timeFrame
- ≤6 month
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.