rSIFN-co in Combination With Total Neo-adjuvant Therapy in Subjects With Mid-low Locally Advanced Rectal Cancer

Summary

This is a multi-center, randomized, phase II study, aimed to evaluate the efficacy of investigational product at a dose of 1800 µg/day when given in combination with TNT. There will be two arms included in this study: Arm A (TNT regimen \+ 1800 µg/day of rSIFN-co treatment) and Arm B (TNT regimen only). Subjects will be randomly assigned to any of the two arms in a 2:1 ratio to receive TNT regimen concurrently with rSIFN-co treatment twice a week or TNT regimen only. The efficacy of rSIFN-co when given in combination with Total Neo-adjuvant Therapy (TNT) will be measured by complete response. Where, complete response is defined as subjects with pathological complete response (pCR) or clinical complete response (cCR).

Timeline

Start

2027-01

Primary completion

2030-01

Completion

2030-06

Drugs

Indications

No indication recorded.