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Recruiting NCT06840665

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

Phase II Interventional Locally Advanced Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD-1 antibody, Oxaliplatin, Capecitabine.
Who it may be relevant to
Registry conditions: Locally Advanced Rectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

Overview

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.

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

Primary outcome measures

  • Pathological complete response (pCR) rate [Time frame: 1 month after the surgery]
Secondary outcome measures (6)
  • Grade 3-4 adverse effects rate [Time frame: From the date of randomization until 3 months after the completion neoadjuvant therapy]
  • Anal function [Time frame: From the date of randomization until 36 months after the surgery]
  • Surgical complication [Time frame: The surgical complications were assessed within 3 months after the surgery]
  • 3-year local recurrence free survival (LRFS) rate [Time frame: From the date of randomization until the date of first documented pelvic failure, assessed up to 36 months]
  • 3-year disease free survival (DFS) rate [Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months]
  • 3-year overall survival (OS) rate [Time frame: From the date of randomization until the date of death from any cause, assessed up to 36 months]

Eligibility criteria

Inclusion criteria

  • Age 18-70 years old, male or female
  • Pathologically confirmed rectal adenocarcinoma
  • The distance from anal verge ≤ 10 cm
  • Clinical stage T3-4 and/or N+
  • No evidence of distance metastases
  • MSI/MMR status: MSS/pMMR
  • Karnofsky score >=70
  • Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy
  • No chemotherapy or any other anti-tumor therapy prior to enrollment
  • No immunotherapy prior to enrollment
  • With good compliance during the study
  • Signed written informed consent

Exclusion criteria

  • Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ
  • Pregnancy or breast-feeding women
  • Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications
  • Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
  • Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy
  • Individuals with autoimmune diseases
  • Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases
  • Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB <1.5 times the upper limit of normal; Cr <1 time the upper limit of normal; Alb ≥30g/L
  • Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
  • Individuals allergic to any drug component of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06840665 · FDRT-2024-293-3847

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗