drugset / Trial / NCT03485027

Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer

NCT03485027

Phase 2 Completed 43 enrolled Fudan University Henan Cancer Hospital · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. For patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. The treatment continues until the disease progression or the untolerable adverse reaction.

Timeline

Start
2018-01-24
Primary completion
2022-12-24
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Cetuximab Monoclonal antibody 500 mg/m2
Subject Irinotecan Small molecule 180 mg/m2
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Raltitrexed Small molecule 2 mg/m2
Subject Raltitrexed Small molecule 3 mg/m2
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2