NCT04636008 Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer
| NCT ID | NCT04636008 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | West China Hospital |
| Condition | Anti-PD-1 Antibody |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-08-14 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2020-08-14 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed rectal adenocarcinoma; 2. With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome; 3. 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; 4. 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)； 5. Men and women ≥18 years of age; 6. Eastern Cooperative Oncology Group performance status score 0 or 1; 7. 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; 8. Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion; 9. Informed consent form signed; 10. Life expectancy of ≥3 months. Exclusion Criteria: 1. Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab; 2. 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; 3. 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; 4. Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion; 5. Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al; 6. Congenital or acquired immunodeficiency such as HIV infection; active Hepatitis B (HBV DNA≥103 copies/mL after regular antiviral therapy); 7. 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); 8. Bleeding tendency or receiving thrombolytic or anticoagulant therapy; 9. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures; 10. Psychiatric disorders that would interfere with cooperation with the requirements of the study; 11. Other conditions that investigators consider not suitable for this study.
Contact & Investigator
Meng Qiu, M.D.
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT04636008 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anti-PD-1 Antibody. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04636008 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04636008 currently recruiting?
Yes, NCT04636008 is actively recruiting participants. Contact the research team at hxqmtg@163.com for enrollment information.
Where is the NCT04636008 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT04636008 clinical trial?
NCT04636008 is sponsored by West China Hospital. The principal investigator is Meng Qiu, M.D. at West China Hospital. The trial plans to enroll 20 participants.