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Short-course RT Followed by NALIRIFOX Plus Pucotenlimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR

NCT07651007 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-06-16

No results posted yet for this study

Summary

The goal of this clinical trial is conducted to evaluate the neoadjuvant regimen of short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy for high-risk locally advanced rectal cancer.

The main questions it aims to answer are:

1. Does this regimen increase the complete response rate ?
2. What medical problems (adverse events) do participants have when receiving this treatment? Researchers will evaluate this regimen compared to historical standard neoadjuvant chemoradiotherapy to see if it achieves a higher complete response rate and improves sphincter preservation.

Participants will:

1. Receive short-course radiotherapy (25Gy/5f) over 5 consecutive days.
2. Then receive NALIRIFOX chemotherapy every 2 weeks for 9 cycles and Pucotenlimab immunotherapy every 3 weeks for 6 cycles (total treatment duration approximately 6 months).
3. Regular checkups and tests during treatment.
4. Keep a diary of their symptoms and the number of times they use a rescue inhaler.

Conditions

  • Advanced Rectal Cancer

Interventions

DRUG

iTNT-HX02

short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy

Sponsors & Collaborators

  • Wang Xin

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-31
Completion
2029-12-31

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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 NCT07651007 on ClinicalTrials.gov