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

Conditions

• Colorectal Liver Metastasis (CRLM)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) — COMBINATION_PRODUCT
  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
• hepatic arterial infusion chemotherapy (HAIC) — PROCEDURE
  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.
• Bevacizumab — DRUG
  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.
• Cetuximab (Erbitux) — DRUG
  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.
• liver resection — PROCEDURE
  If patients reached potential resectable state, we would perform liver resection.

Study Details

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

Key Dates

First listed

May 25, 2025

Start date

May 1, 2023

Status verified

May 2025

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

300 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment group
  Patients in the treatment group would undergo FOLFOX-HAIC combining Bevacizumab or Cetuximab

Primary Outcome Measure

conversion to resection rate [ Time Frame: 180 days ]

Central Contacts

• Zhang Bi Xiang
  862783663400
  [email protected]