NCT05374252

Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients

A Phase 3, Multicenter, Double-Blind Randomized Study of Mitomycin, 5-Fluorouracil and IMRT Combined With or Without Anti-PD-1 in Patients With Locally Advanced Anal Canal Squamous Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multi-center, double-blind randomized controlled trial assessing the efficacy and safety of concurrent mitomycin C/5-Fu chemotherapy and long-course IMRT combined with PD-1 antibody Sintilimab for locally advanced anal canal squamous carcinoma patients, by comparing an experiment group (traditional chemoradiotherapy with PD-1 antibody Sintilimab) with a control group (traditional treatment without Sintilimab).

Conditions

• Anal Canal Cancer Stage III
• Anal Squamous Cell Carcinoma
• Anal Canal Cancer
• Anal Cancer

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	Two cycles of concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil and IMRT, followed by adjuvant sintilimab for six months
RADIATION	concurrent chemoradiotherapy	Two cycles of concurrent mytomicin C and 5-fluorouracil combined with IMRT

Timeline

• Start date: 2022-05-07
• Primary completion: 2025-05-31
• Completion: 2025-12-31
• First posted: 2022-05-16
• Last updated: 2022-05-16

Locations

1 site across 1 country: China