Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental arm Sintilimab+Hypofractionated radiotherapy |
Drug: Sintilimab
Sintilimab+Hypofractionated radiotherapy
Radiation: Hypofractionated Radiotherapy
Hypofractionated Radiotherapy
|
Outcome Measures
Primary Outcome Measures
- Adverse reaction [up to 10 weeks]
Adverse reaction after receiving treatment of Sintilimab combined with hypofractionated radiotherapy and perioperative complications
Secondary Outcome Measures
- Pathological response rate [6-8 weeks after radiotherapy]
Pathological response rate after treatment
- Complete resection rate [6-8 weeks after radiotherapy]
Complete resection rate after treatment
- Quality of life questionnaire [up to 10 weeks]
Quality of life during treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed rectal adenocarcinoma;
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With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome;
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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;
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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)；
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Men and women ≥18 years of age;
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Eastern Cooperative Oncology Group performance status score 0 or 1;
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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;
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Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion;
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Informed consent form signed;
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Life expectancy of ≥3 months.
Exclusion Criteria:
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Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab;
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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;
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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;
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Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion;
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Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al;
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Congenital or acquired immunodeficiency such as HIV infection; active Hepatitis B (HBV DNA≥103 copies/mL after regular antiviral therapy);
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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);
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Bleeding tendency or receiving thrombolytic or anticoagulant therapy;
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Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures;
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Psychiatric disorders that would interfere with cooperation with the requirements of the study;
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Other conditions that investigators consider not suitable for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610041 |
Sponsors and Collaborators
- West China Hospital
- First Affiliated Hospital of Chongqing Medical University
- Yunnan Cancer Hospital
- Sichuan Cancer Hospital and Research Institute
- Chengdu Third People's Hospital
- The Affiliated Hospital Of Southwest Medical University
Investigators
- Principal Investigator: Meng Qiu, M.D., West China Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201919