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Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squamous Cell Carcinoma

NCT07692152 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-07-09

No results posted yet for this study

Summary

This is a prospective, multicenter, open-label, phase III randomized controlled clinical trial designed to evaluate the efficacy and safety of replacing the traditional chemotherapeutic drug mitomycin with the PD-1 inhibitor sintilimab in definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma. The study plans to enroll 350 previously untreated patients with limited-stage anal squamous cell carcinoma and randomize them in a 1:1 ratio into two groups: the control group will receive the current standard treatment, namely intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and mitomycin; the experimental group will receive an innovative "immunotherapy replacement" regimen, namely IMRT of the same technique concurrent with capecitabine and sintilimab. The study adopts a dual primary endpoint design, aiming to verify that the experimental group is non-inferior to the control group in the clinical complete response rate at 6 months after radiotherapy, and is significantly superior to the control group in the incidence of grade 3 or higher treatment-related acute toxicities.

Conditions

  • Anal Squamous Cell Carcinoma, Limited-stage

Interventions

DRUG

Capecitabine

Oral capecitabine at 825 mg/m² twice daily on days of radiotherapy, concurrent with IMRT, as part of the chemoradiotherapy backbone for both study arms.

BIOLOGICAL

Sintilimab

Intravenous sintilimab at 200 mg every 3 weeks, administered concurrently with capecitabine and IMRT to the experimental arm as an immunotherapy replacement for mitomycin.

RADIATION

Intensity-Modulated Radiotherapy (IMRT)

Intensity-modulated radiotherapy (IMRT) will be administered: * Primary tumor: 1.8 Gy per fraction, 28-30 fractions, total dose 50.4-54 Gy; * Metastatic lymph nodes: 1.68-1.8 Gy per fraction, 30 fractions, total dose 50.4-54 Gy; * Elective nodal regions: 1.5 Gy per fraction, 28-30 fractions, total dose 42-45 Gy; Treatment will be administered 5 days per week, concurrently with systemic chemotherapy (capecitabine ± mitomycin/sintilimab), in accordance with institutional standard practice for anal squamous cell carcinoma.

DRUG

Mitomycin (MMC)

Intravenous mitomycin at 10 mg/m² as a single bolus dose on day 1 of radiotherapy, administered only to the control arm as part of the standard chemoradiotherapy regimen.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Jing Jin, MD, PhD · Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT07692152 on ClinicalTrials.gov