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

Recruiting now · Phase 1/Phase 2

Conditions studied: Anti-PD-1 Antibody, Radiotherapy, Rectal Cancer, MSI-H, Mmr Deficiency

In brief

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.

Key facts

Study ID

NCT04636008

Run by

West China Hospital

People needed

20

Starts

2020-08-14

Expected to finish

2024-12-01

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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