A Phase 3 interventional study of FUDR and Oxaliplatin in Colorectal Cancer, Liver Metastases and HAI, sponsored by Sun Yat-sen University. Terminated at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.
Numerous retrospective studies have indicated a positive synergistic effect of combining adjuvant oxaliplatin/irinotecan-based doublet systemic chemotherapy and hepatic arterial infusion (HAI) for colorectal cancer (CRC) patients following colorectal cancer liver metastases (CRLM) resection. However, this strategy has not been evaluated prospectively to date. HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 92 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive systemic chemotherapy on days 1 and 15 using either of the following regimens: mFOLFOX6 (Oxaliplatin 85 mg/m2; Leucovorin 200mg/m2; followed by an infusion of 5-fluorouracil 2.4 g/m2 administered over 46 hours) or mFOLFIRI (Irinotecan 180mg/m2; Leucovorin 200mg/m2; followed by an infusion of 5-fluorouracil 2.4 g/m2 administered over 46 hours) For HAI, FUDR was administered as a continuous infusion of 0.12 mg/kg/day over 14 days via the HAI pump, along with dexamethasone 20 mg, and normal saline was used to fill up the 300ml pump reservoir.
Drug: FUDR · Drug: Oxaliplatin · Drug: Leucovorin · Drug: 5FU · Drug: Irinotecan
Patients will receive systemic chemotherapy on days 1 and 15 using either of the following regimens: mFOLFOX6 (oxalipatin 85 mg/m2 infusion for 3 h, Leucovorin 200 mg/m2 for 3 h and 5-FU 2,400 mg/m2 continuous infusion for 46 h) or mFOLFIRI (Irinotecan 180mg/m2; Leucovorin 200mg/m2; 5-FU 2,400 mg/m2 continuous infusion for 46 h).
Drug: Oxaliplatin · Drug: Leucovorin · Drug: 5FU · Drug: Irinotecan
Floxuridine(FUDR) 0.12 mg/kg/day,on Day 1-14 through the HAI pump.
Also known as: Floxuridine
Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.
Also known as: Xaliplatin
Leucovorin 200mg/m2 ivd over 2 hours on Day 1
Also known as: Folinic Acid
5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
Also known as: 5-Fluorouracil
Irinotecan 180mg/m2
Also known as: CPT-11
3 Year Relapse Free Survival Rate
Calculated from the time of liver metastasectomy to the time of recurrence or death, whichever came first or censored at the date of the last follow-up for recurrence-free patients that were still alive
Time frame: up to 36 months
Overall Survival
From date of randomization until the date of death from any cause, assessed up to 5 years
Time frame: up to 5 years
Treatment-related adverse events
Number of patients with adverse events and severity measured according to the NCI CTC 3.0 criteria
Time frame: Up to 36 months
Liver-specific RFS
Measure of the time period during which a patient remains free from the recurrence of liver-related events
Time frame: Up to 36 months
Serum ctDNA methylation levels
The methylation status of blood ctDNA at a specific time point (e.g., postoperatively) was considered positive if either of the two markers (SEPT9 and NPY) yielded results above zero. Conversely, it was deemed negative if both markers showed an absence of methylation.
Time frame: Up to 5 years
Plan to share: Undecided — Study Protocol
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This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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