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

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).

NCT Number	NCT07662278
Lead Sponsor	Sichuan Huiyang Life Science and Technology Corporation
Conditions	Mid-low Locally Advanced Rectal Cancer
Enrollment	90 participants
Start Date	2027-01
Primary Completion	2030-01 (estimated)
Study Completion	2030-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-23