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RECRUITING
NCT06988852
PHASE2

FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

Try FOLFOX-HAIC combining bevacizumab or cetuximab for initially unresectable colorectal liver metastasis patients to increase the conversion to resection rate to improve long-term survival outcomes

Official title: Conversion Treatment With Hepatic Arterial Infusion of Oxaliplatin, Leucovorin and Fluorouracil Plus Intravenous Bevacizumab or Cetuximab for Initially Unresectable Colorectal Liver Metastasis: A Prospective Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2023-05-01

Completion Date

2030-12-31

Last Updated

2025-05-25

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

The procedures of FOLFOX-HAIC were as follows: 1) a 5 French sheath was inserted into the femoral artery by Seldinger technique, then a 3.5 French catheter entered the coeliac trunk and superior mesenteric artery to assess the feeding arteries of tumors and identify any extra-collateral vessels which may cause drug leakage. These vessels would be embolized with gelatin sponge particles or metallic coils if necessary. A 2.7 French microcatheter was selectively inserted into the left/right/proper hepatic artery then patients were transferred to inpatient ward to start chemotherapy drug infusion. The FOLFOX regimen involving oxaliplatin (130mg/m2, day 1, 0-2h), leucovorin (400 mg/m2, day 1, 2-3h), 5-Fu (400mg/m2, day 1, bolus at 3h, then 2400 mg/m2, day 1-3, 3-49h), was administered via the microcatheter. The microcatheter and sheath were removed after HAIC finished. We didn't implanted port catheter system and repeated percutaneous femoral artery puncture and catheterization once every 3

PROCEDURE

hepatic arterial infusion chemotherapy (HAIC)

The procedures of FOLFOX-HAIC were as follows: 1) a 5 French sheath was inserted into the femoral artery by Seldinger technique, then a 3.5 French catheter entered the coeliac trunk and superior mesenteric artery to assess the feeding arteries of tumors and identify any extra-collateral vessels which may cause drug leakage. These vessels would be embolized with gelatin sponge particles or metallic coils if necessary. A 2.7 French microcatheter was selectively inserted into the left/right/proper hepatic artery then patients were transferred to inpatient ward to start chemotherapy drug infusion.

DRUG

Bevacizumab

We would inject bevacizumab at the dose of 7.5mg/kg once every 3 weeks if the primary tumors located from right-side to splenic flexure colon or the genotype of RAS or RAF was mutational.

DRUG

Cetuximab (Erbitux)

We would inject cetuximab at an initial dose of 400mg/m2 and maintained a dose of 250mg/m2 once every week if we didn't choose bevacizumab.

PROCEDURE

liver resection

If patients reached potential resectable state, we would perform liver resection.

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China