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The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer

NCT05555888 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-01-15

No results posted yet for this study

Summary

The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

Conditions

  • Early Low Rectal Cancer

Interventions

DRUG

PD-1 antibody

PD-1 antibody (Toripalimab): 240mg d1 q3w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUG

Oxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

RADIATION

Short-course radiotherapy

Shor-course radiotherapy: 25Gy/5Fx

Sponsors & Collaborators

  • Fudan University

    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
2022-12-12
Primary Completion
2024-03-12
Completion
2025-05-01

Countries

  • China

Study Locations

More Related Trials

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 NCT05555888 on ClinicalTrials.gov