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Recruiting NCT04636008

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

Phase I / Phase II Interventional Anti-PD-1 Antibody Radiotherapy Rectal Cancer MSI-H

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: Sintilimab, Hypofractionated Radiotherapy.
Who it may be relevant to
Registry conditions: Anti-PD-1 Antibody, Radiotherapy, Rectal Cancer, MSI-H. Basic parameters: from 18 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

The Safety and Efficacy of Sintilimab Combined With Hypofractionated Radiotherapy in MSI-H/dMMR Rectal Cancer: a Prospective, Single-arm, Multicenter, Phase Ib Study

Overview

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.

Detailed description

The patients meet the inclusion criteria. After signing the informed consent, they are given radiotherapy 5Gyx5 and sintilimab 200mg ivgtt D1, D15, D29. Radical surgery is performed 6-8 weeks after radiotherapy.

Interventions

  • Drug Sintilimab
    Sintilimab+Hypofractionated radiotherapy
  • Radiation Hypofractionated Radiotherapy
    Hypofractionated Radiotherapy

Primary outcome measures

  • Adverse reaction [Time frame: up to 10 weeks]
Secondary outcome measures (3)
  • Pathological response rate [Time frame: 6-8 weeks after radiotherapy]
  • Complete resection rate [Time frame: 6-8 weeks after radiotherapy]
  • Quality of life questionnaire [Time frame: up to 10 weeks]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed rectal adenocarcinoma;
  • With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome;
  • Not received any anti-rectal cancer treatment previously; for patients with Lynch syndrome, not received any anti-tumor therapy about rectal cancer diagnosed this time;
  • No distant metastasis except for lateral lymph nodes on thoracic and abdominal enhanced computed tomography (CT) scans; the distance between tumor's lower edge and anus within 15cm; clinical T stage ≥T2 on high-resolution pelvic magnetic resonance imaging (MRI)；
  • Men and women ≥18 years of age;
  • Eastern Cooperative Oncology Group performance status score 0 or 1;
  • Adequate hematologic, hepatic, renal, thyroid and cardiac function: hemoglobin ≥90 g/L, neutrophils ≥1500/mm3, platelets ≥75,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.5 × ULN; creatinine ≤1.5 × ULN, creatinine clearance ≥50 mL/min; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; serum albumin ≥28 g/L；thyroid stimulating hormone and free thyroxine within ±10% of normal levels; no obvious abnormality in electrocardiogram;
  • Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion;
  • Informed consent form signed;
  • Life expectancy of ≥3 months.

Exclusion criteria

  • Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab;
  • Other malignancy history with disease free survival <5 years, except for curative in situ cervical cancer, curative skin basal cell carcinoma and curative gastrointestinal cancer by endoscopic mucoresection;
  • Current or past history of autoimmune diseases, including but not limited to: interstitial lung disease, uveitis, enteritis，active hepatitis (HBV DNA≥103 copies/mL after regular antiviral therapy)，nephritis, hyperthyroidism and hypothyroidism;
  • Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion;
  • Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al;
  • Congenital or acquired immunodeficiency such as HIV infection; active Hepatitis B (HBV DNA≥103 copies/mL after regular antiviral therapy);
  • Having one of the following complications: massive gastrointestinal hemorrhage, gastrointestinal perforation or obstruction; symptomatic heart diseases including unstable angina, myocardial infarction and heart failure; uncontrollable diabetes mellitus or hypertension; uncontrollable diarrhea (interfering with daily activities although receiving adequate treatment);
  • Bleeding tendency or receiving thrombolytic or anticoagulant therapy;
  • Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures;
  • Psychiatric disorders that would interfere with cooperation with the requirements of the study;
  • Other conditions that investigators consider not suitable for this 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
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Publications

  • Li X, Fang C, Wang X, Yu Y, Wang Z, Qiu M. Neoadjuvant treatment of sintilimab plus hypofractionated radiotherapy for MSI-H/dMMR rectal cancer: A prospective, multicenter, phase Ib study. Cancer Med. 2022 Dec;11(23):4405-4410. doi: 10.1002/cam4.4720. Epub 2022 Mar 29. PMID 35352512

Identifiers

NCT: NCT04636008 · 201919

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗