NCT07333053

Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

FOLFOX-Based Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer: An Open-Label, Multicenter, Randomized, Controlled, Phase Ⅱ Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Quanda Liu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, and open-label clinical trial. It is initiated to determine the efficacy of FOLFOX-based, transarterial infusion chemotherapy (TAIC) combined with either cetuximab or bevacizumab for patients with unresectable colorectal cancer (CRC).

Detailed description

Current CRC treatment options include surgical resection, intravenous chemotherapy (IVC), radiation therapy, immunotherapy, and targeted therapy, or a combination of these options. IVC is an important therapy for CRC. Unfortunately, IVC results in broad drug distribution, while achieving with relatively low drug accumulation within the tumor. Compared with IVC, TAIC can increase the local intra-tumoral concentrations of chemotherapeutic agents by intensifying drug delivery into the tumor via super-selective catheterization of the tumor-feeding artery, and meanwhile reduce systematic toxicity. Hepatic artery infusion chemotherapy (HAIC) has been shown to yield significantly better outcomes than conventional transarterial chemoembolization (TACE) or IVC, and is now widely used for primary liver cancer and secondary liver malignancies. Based on these experiences, the investigators hypothesize that TAIC is clinically more effective at the same dose than IVC in the treatment of unresectable CRC. However, there is currently no high-quality evidence from clinical trials to support this hypothesis. To address this gap, the investigators will conduct a prospective study to verify this hypothesis. Eligible patients are those with unresectable CRC, those intolerant to surgical resection, and those with microsatellite instability or microsatellite instability low or proficient mismatch repair CRC. A total of 30 patients will be randomly assigned to the IVC group or TAIC group. Patients in the IVC group will receive the FOLFOX-based IVC with either cetuximab or bevacizumab every two weeks for a total of 8 weeks. Patients in the TAIC group will undergo FOLFOX-based TAIC combined with either cetuximab or bevacizumab on weeks 0 and 4 and will receive FOLFOX-based IVC with either cetuximab or bevacizumab on weeks 2 and 6. The primary endpoints are the objective response rate (ORR) and disease control rate (DCR).

Conditions

• Unresectable Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Transarterial infusion chemotherapy (TAIC)	TAIC can increase the local intra-tumoral concentrations of chemotherapeutic agents by intensifying drug delivery into the tumor via super-selective catheterization of the tumor-feeding artery, and meanwhile reduce systematic toxicity.
PROCEDURE	Intravenous Chemotherapy（IVC）	Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-01-12
• Last updated: 2026-03-06

Locations

1 site across 1 country: China