Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04636008

Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer

Led by West China Hospital · Updated on 2024-08-06

20

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

Sponsors

W

West China Hospital

Lead Sponsor

F

First Affiliated Hospital of Chongqing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)/ DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.

CONDITIONS

Official Title

Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed rectal adenocarcinoma
  • DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, regardless of Lynch syndrome
  • No prior anti-rectal cancer treatment; for Lynch syndrome patients, no prior anti-tumor therapy for this diagnosis
  • No distant metastasis except lateral lymph nodes; tumor lower edge within 15 cm of anus; clinical T stage 65T2 by pelvic MRI
  • Men and women aged 18 years or older
  • Eastern Cooperative Oncology Group performance status score of 0 or 1
  • Adequate blood, liver, kidney, thyroid, and heart function as defined by specified laboratory thresholds
  • No blood, blood products, or hematopoietic growth factor use within 2 weeks before inclusion
  • Signed informed consent form
  • Life expectancy of 3 months or longer
Not Eligible

You will not qualify if you...

  • History of allergic diseases or severe hypersensitivity to drugs, antibody products, or Sintilimab
  • Other malignancy history with disease-free survival less than 5 years, except certain curable cancers
  • Current or past autoimmune diseases including interstitial lung disease, uveitis, enteritis, active hepatitis, nephritis, hyperthyroidism, or hypothyroidism
  • Use of immunosuppressants or corticosteroids within 2 weeks before inclusion
  • Severe infections requiring intravenous antibiotics, antifungal, or antiviral drugs
  • Congenital or acquired immunodeficiency such as HIV infection or active hepatitis B
  • Complications such as massive gastrointestinal hemorrhage, perforation, obstruction, unstable heart diseases, uncontrolled diabetes or hypertension, or severe diarrhea
  • Bleeding tendency or use of thrombolytic or anticoagulant therapy
  • Pregnant or breastfeeding women; unwillingness to use contraception
  • Psychiatric disorders interfering with study cooperation
  • Other conditions deemed unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

Loading map...

Research Team

M

Meng Qiu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here