Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:45 PM
Study NCT ID:
NCT04636008
Status:
RECRUITING
Last Update Posted:
2024-08-06
First Post:
2020-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'C536928', 'term': 'Turcot syndrome'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'D000069473', 'term': 'Radiation Dose Hypofractionation'}], 'ancestors': [{'id': 'D019583', 'term': 'Dose Fractionation, Radiation'}, {'id': 'D011879', 'term': 'Radiotherapy Dosage'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-03', 'studyFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2020-11-14', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse reaction', 'timeFrame': 'up to 10 weeks', 'description': 'Adverse reaction after receiving treatment of Sintilimab combined with hypofractionated radiotherapy and perioperative complications'}], 'secondaryOutcomes': [{'measure': 'Pathological response rate', 'timeFrame': '6-8 weeks after radiotherapy', 'description': 'Pathological response rate after treatment'}, {'measure': 'Complete resection rate', 'timeFrame': '6-8 weeks after radiotherapy', 'description': 'Complete resection rate after treatment'}, {'measure': 'Quality of life questionnaire', 'timeFrame': 'up to 10 weeks', 'description': 'Quality of life during treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anti-PD-1 Antibody', 'Radiotherapy', 'Rectal Cancer', 'MSI-H', 'Mmr Deficiency']}, 'referencesModule': {'references': [{'pmid': '35352512', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically confirmed rectal adenocarcinoma;\n2. With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome;\n3. 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;\n4. 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)；\n5. Men and women ≥18 years of age;\n6. Eastern Cooperative Oncology Group performance status score 0 or 1;\n7. 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;\n8. Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion;\n9. Informed consent form signed;\n10. Life expectancy of ≥3 months.\n\nExclusion Criteria:\n\n1. Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab;\n2. 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;\n3. 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;\n4. Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion;\n5. Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al;\n6. Congenital or acquired immunodeficiency such as HIV infection; active Hepatitis B (HBV DNA≥103 copies/mL after regular antiviral therapy);\n7. 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);\n8. Bleeding tendency or receiving thrombolytic or anticoagulant therapy;\n9. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures;\n10. Psychiatric disorders that would interfere with cooperation with the requirements of the study;\n11. Other conditions that investigators consider not suitable for this study."}, 'identificationModule': {'nctId': 'NCT04636008', 'briefTitle': 'Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'The Safety and Efficacy of Sintilimab Combined With Hypofractionated Radiotherapy in MSI-H/dMMR Rectal Cancer: a Prospective, Single-arm, Multicenter, Phase Ib Study', 'orgStudyIdInfo': {'id': '201919'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Sintilimab+Hypofractionated radiotherapy', 'interventionNames': ['Drug: Sintilimab', 'Radiation: Hypofractionated Radiotherapy']}], 'interventions': [{'name': 'Sintilimab', 'type': 'DRUG', 'description': 'Sintilimab+Hypofractionated radiotherapy', 'armGroupLabels': ['Experimental arm']}, {'name': 'Hypofractionated Radiotherapy', 'type': 'RADIATION', 'description': 'Hypofractionated Radiotherapy', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meng Qiu, M.D.', 'role': 'CONTACT', 'email': 'hxqmtg@163.com', 'phone': '+86-28-85422589'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Meng Qiu, M.D.', 'role': 'CONTACT', 'email': 'hxqmtg@163.com', 'phone': '+86-28-85422589'}], 'overallOfficials': [{'name': 'Meng Qiu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, {'name': 'Yunnan Cancer Hospital', 'class': 'OTHER'}, {'name': 'Sichuan Cancer Hospital and Research Institute', 'class': 'OTHER'}, {'name': "Chengdu Third People's Hospital", 'class': 'UNKNOWN'}, {'name': 'The Affiliated Hospital Of Southwest Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Meng Qiu', 'investigatorAffiliation': 'West China Hospital'}}}}