Comparing two chemotherapy combinations as first treatment for advanced colorectal cancer
Compares two chemotherapy regimens with bevacizumab or cetuximab in adults with metastatic colorectal cancer.
Plain-language title generated from the registry record
Registry title: FOLFOX8 Versus mFOLFOX6 With Bevacizumab or Cetuximab for First-Line Unresectable Metastatic Colorectal Cancer (Phase II)
Key facts
- Where
- Guangzhou and Shanghai, ChinaSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer that has spread and cannot be removed by surgery, who have not yet had treatment for it.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Colorectal cancer that has spread to other parts of the body and cannot be removed by surgery, confirmed by tissue or cell testing. Expected survival of more than 3 months.
- Earlier treatment
- No earlier treatment for the unresectable or spread-out disease.
- Biomarker or test result
- People with MSI-H or dMMR colorectal cancer, or a BRAF mutation, cannot join.
Main reasons for not taking part
- Known allergy to the study drugs or their ingredients
- Pregnant or breastfeeding women
- Another cancer within the last 2 years (some small, localized tumors are allowed)
- Illness that makes chemotherapy unsafe, or a condition for which chemotherapy is not allowed
- Taking part in another drug trial within the last 4 weeks
Read by machine on 9 November 2026.
Where in China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaNo longer taking part
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- Fudan University Shanghai Cancer CenterShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sun Yat-sen University
- Trial code
- NCT07621497
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥ 18 years, male or female; ECOG performance status 0-2; Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no prior treatment for unresectable or metastatic disease; 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; Expected survival > 3 months.
Exclusion: Contraindications to chemotherapy; 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; Participation in another clinical trial of an investigational drug within 4 weeks prior to randomization; Known allergy to the study drug(s) and/or their excipients; Patients with MSI-H or dMMR colorectal cancer; Patients with systemic medical or psychiatric disorders that make them unsuitable for chemotherapy; Patients with BRAF mutation; Pregnant or breastfeeding women; Patients deemed unsuitable for enrollment in this study by the investigator's judgment.