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Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

NCT06204094 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-04-24

No results posted yet for this study

Summary

phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

RADIATION

node-sparing short-course radiotherapy

5Gy\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes

DRUG

Sintilimab

200mg intravenous infusion d1 of each cycle\*6cycles

DRUG

Capecitabine

1000mg/m2, PO, BID, d1-14 of each cycle\*6cycles

DRUG

Oxaliplatin

130mg/m2, intravenous infusion,d1 of each cycle\*6cycles

PROCEDURE

TME surgery

laparoscopic or robotic TME surgery for non-cCR patients

PROCEDURE

watch and wait

WW for cCR patients

Sponsors & Collaborators

  • Jinhua Central Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2027-09-01
Completion
2028-09-01

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 NCT06204094 on ClinicalTrials.gov