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MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

NCT06840665 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-02-21

No results posted yet for this study

Summary

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

PD-1 antibody

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

DRUG

Oxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 bid d1-14 q3w

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2026-08-12
Completion
2027-02-12

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 NCT06840665 on ClinicalTrials.gov