drugset / Trial / NCT05018182

FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer

NCT05018182 ↗

Phase 2 Unknown 69 enrolled West China Hospital
NaSingle-groupOpen-labelTreatment

Summary

The main cause of recurrence after surgical treatment of colorectal cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. The FOLFOXIRI regimen has been shown to have a high objective efficiency in advanced colorectal cancer. This phase II trial is to explore the pathological remission rate and safety of stage II/III locally advanced colon cancer with high risk of recurrence to FOLFOXIRI regimen of neoadjuvant chemotherapy alone.

Timeline

Start
2021-08-02
Primary completion
2022-04
Completion
2022-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 150 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject Oxaliplatin Small molecule 130 mg/m2 —
Subject fluorouracil Small molecule 2800 mg/m2 Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral

Indications