NCT03485027

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

Completed Phase 2 Last updated 8 December 2023

What this trial tests

Phase 2 trial testing the rechallenge regimen in Metastatic Colorectal Cancer in 43 participants. Completed in 1 July 2023.

Timeline

24 January 2018

Primary endpoint
24 December 2022

1 July 2023

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	24 January 2018
Primary completion	24 December 2022
Estimated completion	1 July 2023
Sites	1 location across China

Drugs / interventions tested

• the rechallenge regimen — full drug profile →

Conditions studied

• Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
• Chemotherapy Effect — all drugs for Chemotherapy Effect →

Sponsor

Fudan University

Who can join

Adults 18 to 80, any sex, with Metastatic Colorectal Cancer or Chemotherapy Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. What Is Next for Refractory Colorectal Cancer CRC? Looking Beyond SUNLIGHT, FRESCO2, RECURSE and CORRECT.
   Cherri S, Libertini M, Noventa S, Oneda E, et al · · 2025 · cited 7× · PMID 40141164 · DOI 10.3390/ijms26062522