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

NCT07662278 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-06-23

No results posted yet for this study

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).

Conditions

  • Mid-low Locally Advanced Rectal Cancer

Interventions

DRUG

Recombinant Super-Compound Interferon (rSIFN-co)

Subjects will receive the reconstituted rSIFN-co lyophilized powder via rectum and anus, twice a week

DRUG

Total Neo-adjuvant therapy

each subject will receive short-course radiotherapy (RT) (25 Gy in 5 fractions) followed by chemotherapy (6 cycles of CAPEOX), after 2-week rest.

Sponsors & Collaborators

  • Sichuan Huiyang Life Science and Technology Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2030-01-31
Completion
2030-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07662278 on ClinicalTrials.gov