High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial aims to evaluate the efficacy, safety of high-dose FOLFIRI regimen in advanced colorectal cancer patients with wild-type UGT1A1*6 and *28.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Treatments: Camptothecin; Fluorouracil; Irinotecan

Criteria

Inclusion Criteria:

• Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence

• Patients should be with UGT1A1*28 wild-type TA6/6 and UGT1A1*6 wild-type G/G

• Patients have measurable lesions

• Patients are not available for targeted therapy or patients refuse to receive targeted therapy

• Age should be more than 18 years

• Performance status should be 0-2

• Hemoglobin should be more than 9.0 g/dL; Absolute Neutrophil Count should be more than 1,500/mm3; Platelet should be more than 80,000/mm3；Total Bilirubin should be less than 1.5 times of the upper limit of normal value; Alanine aminotransferase and Glutamic-oxaloacetic transaminase should less than 2.5 times of the upper limit of normal value (it can be 5 times if liver metastasis); Creatinine should be be less than 1.5 times of the upper limit of normal value

Exclusion Criteria:

• Patients with UGT1A1*28 wild-type TA6/7, TA7/7 and UGT1A1*6 wild-type G/A,A/A;

• Patients with brain metastases;

• Patients could not tolerate chemotherapy;

• Patients have secondary primary tumor;