A Phase 3 interventional study of mFOLFOXIRI plus Cetuximab and mFOLFOXIRI Plus Bevacizumab in Colorectal Cancer and Liver Metastases, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
Evidence suggests that the addition of cetuximab or bevacizumab to doublet regimens could improve response rate and resectability rate of liver metastases and survival in colorectal liver metastases (CRLM). Moreover, it is observed that FOLFOXIRI yields higher response and resection rates compared with doublet regimens. However, which is better in conversion therapy of RAS/BRAF wild-type initially unresectable CRLM, FOLFOXIRI plus cetuximab or bevacizumab, remains unknown.
In this study, RAS/BRAF wild-type colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be randomised between modified FOLFOXIRI (mFOLFOXIRI) plus cetuximab and mFOLFOXIRI plus bevacizumab. Patient imaging will be reviewed for resectability by MDT, consisting of at least one radiologist and three liver surgeons every assessment. MDT review will be performed prior to randomization as well as during treatment, as described in the protocol.
Patients will be stratified for primary tumor location (right-sided or left sided) and numbers of liver metastases (\<5 or ≥5).
Patients with RAS/BRAF wild-type primary tumors will be randomized between mFOLFOXIRI plus cetuximab (cetuximab 500 mg/m\^2 in 60 minutes i.v., followed by oxaliplatin 85 mg/m\^2 i.v. in 120 minutes, followed by irinotecan 165 mg/m\^2 i.v. in 60 minutes, together with leucovorin 400 mg/m\^2 i.v. in 120 minutes, followed by continuous infusion of 5-fluorouracil 2400 mg/m\^2 in 46 hours, every 2 weeks) or mFOLFOXIRI plus bevacizumab (Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by oxaliplatin 85 mg/m\^2 i.v. in 120 minutes, followed by irinotecan 165 mg/m\^2 i.v. in 60 minutes, together with leucovorin 400 mg/m\^2 i.v. in 120 minutes, followed by continuous infusion of 5-fluorouracil 2400 mg/m\^2 in 46 hours, every 2 weeks).
Patients will be evaluated every 8 weeks by MRI or CT scan for disease status. The assigned systemic treatment should be continued for at least 6 months or earlier in case of resectability, progression of disease, unacceptable toxicity, or patient refusal. If after 6 months MDT concludes that the patient is still not resectable, it is highly unlikely that resectability will be achieved at all. Therefore the chemotherapy regimen may be reconsidered after 6 months of treatment.
In patients who will become resectable and undergo secondary surgery of liver metastases, the total duration of preoperative and postoperative treatment together should be 6 months. However, the postoperative chemotherapy regimen was determined by the investigator.
After 70% of patients were enrolled and conversion therapy were finished, a mid-term analysis will be performed.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 508 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
Drug: mFOLFOXIRI plus Cetuximab
Drug: mFOLFOXIRI Plus Bevacizumab
cetuximab 500mg/m2 + oxaliplatin 85 mg/m2 + irinotecan 165 mg/m2 + folinic acid 400 mg/m2 + 5-fluorouracil 2400 mg/m2 46h infusion starting on day 1, every 2 weeks
bevacizumab 5mg/kg + oxaliplatin 85 mg/m2 + irinotecan 165 mg/m2 + folinic acid 400 mg/m2 + 5-fluorouracil 2400 mg/m2 46h infusion starting on day 1, every 2 weeks
Conversion resection rate of liver metastases
Rate of conversion from initially unresectable liver metastases to resectable ones
Time frame: up to 6 months
Objective Response Rate
rate of objective response for therapy
Time frame: up to 6 months
Incidence of adverse events
Incidence of adverse events
Time frame: up to 6 months
Progression-Free Survival
Progression free survival
Time frame: up to 3 years
Overall Survival
overall survival
Time frame: up to 3 years
Early tumor shrinkage
The rates of tumor shrinkage by RECIST at 8 weeks
Time frame: at 8 weeks
Best deepness of response
the maximum tumor shrinkage rates by RECIST during the treatment of the study
Time frame: up to 6 months
time interval from chemotherapy to hepatectomy
Time interval from the beginning of treatment to hepatectomy
Time frame: up to 6 months
Plan to share: No
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