CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 enrolled
Drug / intervention
xintilimab injection +1 moredrug
Likely dose
xintilimab injection 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05215379
NCT05215379Phase 3Completed

Multicenter Prospective Randomized Clinical Trial of Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer

Changhai Hospital·interventional·Posted Jan 31, 2022·Updated Jan 2, 2026

In Brief

A Phase 3 clinical trial evaluating xintilimab injection and Control for Neoadjuvant Chemoradiation Therapy and 3 related conditions. Completed, enrolled 201 participants across 1 site.

Detailed Summary

At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer" in order to provide a high-level evidence-based medical evidence for ultra-low rectal cancer treatment and improve ultra-low rectal cancer diagnosis and treatment effect.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJan 31, 2022
Enrollment StartOct 1, 2022
Primary CompletionDec 30, 2024
Study CompletionJun 24, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.4 years ago

Interventions

xintilimab injectiondrug

neoadjuvant chemoradiation therapy +xintilimab injection 200mg/3week 4cycle

Controlother

neoadjuvant chemoradiation therapy