Clinical trial · Interventional
FOLFOX8 Versus mFOLFOX6 With Bevacizumab or Cetuximab for First-Line Unresectable Metastatic Colorectal Cancer (Phase II)
A Prospective, Multicenter, Randomized Controlled, Phase II Study to Evaluate the Efficacy and Safety of FOLFOX8 Versus mFOLFOX6 Combined With Bevacizumab or Cetuximab as First-Line Treatment for Unresectable Metastatic Colorectal Cancer
- 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)
This is a prospective, multicenter, randomized controlled, phase II study. It is expected to enroll 229 patients and aims to evaluate the efficacy and safety of FOLFOX8 versus mFOLFOX6 combined with bevacizumab or cetuximab as first-line treatment for unresectable metastatic colorectal cancer. The primary objective is to assess progression-free survival (PFS) of the patients. Secondary objectives include assessment of objective response rate (ORR), overall survival (OS), safety, and other outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Calcium Folinate | Drug | Immunomodulatory Oligonucleotide | ALIAS |
| Cetuximab (EGFR inhibitor) | Drug | Cetuximab | ALIAS |
| Levofolinic Acid For Injection | Drug | Levoleucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFOX8
- description
- Patients receive oxaliplatin, 5-FU bolus, and a concurrent infusion of Levofolinic Acid For Injection mixed with 5-FU, repeated every 2 weeks for up to 12 cycles. From cycle 2 onward, bevacizumab or cetuximab is added based on RAS mutation status and tumor location. After 12 cycles, patients without disease progression enter maintenance therapy with concurrent infusion of Levofolinic Acid For Injection mixed with 5-FU (without oxaliplatin) plus continued targeted therapy , repeated every 2 weeks until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Oxaliplatin
- Drug: 5-Fluorouracil
- Drug: Levofolinic Acid For Injection
- Drug: Bevacizumab
- Drug: Cetuximab (EGFR inhibitor)
- type
- ACTIVE_COMPARATOR
- label
- mFOLFOX6
- description
- Patients receive oxaliplatin, calcium folinate, 5-FU bolus, and 5-FU continuous infusion, repeated every 2 weeks for up to 12 cycles. From cycle 2 onward, bevacizumab or cetuximab is added based on RAS mutation status and tumor location. After 12 cycles, patients without disease progression enter maintenance therapy with calcium folinate, 5-FU bolus, and 5-FU continuous infusion (without oxaliplatin) plus continued targeted therapy , repeated every 2 weeks until disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years, male or female. 2. ECOG performance status 0-2. 3. Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no prior treatment for unresectable or metastatic disease. 4. Adequate organ function: Hb ≥ 70 g/L; WBC ≥ 3.0×10⁹/L; NEUT ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; AST and ALT ≤ 3× ULN; sCr ≤ 2× ULN; TBIL ≤ 2× ULN. 5. Expected survival \> 3 months. Exclusion Criteria: 1. Known allergy to the study drug(s) and/or their excipients. 2. Contraindications to chemotherapy. 3. Patients with MSI-H or dMMR colorectal cancer. 4. Patients with BRAF mutation. 5. Pregnant or breastfeeding women. 6. History of any second malignancy within 2 years prior to randomization, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, or breast carcinoma in situ, which are allowed for enrollment. 7. Patients with systemic medical or psychiatric disorders that make them unsuitable for chemotherapy. 8. Patients deemed unsuitable for enrollment in this study by the investigator's judgment. 9. Participation in another clinical trial of an investigational drug within 4 weeks prior to randomization.
References
Publications (0)
Data not yet available