Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-02 @ 9:33 PM
Study NCT ID:
NCT04189094
Status:
UNKNOWN
Last Update Posted:
2019-12-06
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 years', 'description': 'PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'OS, measured from the date of randomization to the date of death from any cause.'}, {'measure': 'Overall response rates', 'timeFrame': '2 years', 'description': 'ORR, tumor response will be measured by using the RECIST 1.1.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiotherapy', 'chemotherapy', 'immunotherapy', 'PD-1 inhibitor', 'lung cancer', 'small cell', 'limited-stage'], 'conditions': ['Small Cell Lung Cancer Limited Stage']}, 'descriptionModule': {'briefSummary': 'The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically/cytologically confirmed diagnosis of SCLC.\n2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.\n3. Patients should be ≥ 18 years old.\n4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).\n5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.\n6. With weight loss no more than 10% within 6 months before diagnosis.\n7. Informed consent must be signed.\n\nExclusion Criteria:\n\n1. Histology confirmed the mixed NSCLC components;\n2. Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);\n3. Any disease or condition contraindicated by radiotherapy or chemotherapy;\n4. Malignant pleural effusion and pericardial effusion;\n5. Pregnant and lactating women;\n6. History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia;\n7. Received live vaccination within 28 days before the first administration of the study drug;\n8. 28 days prior to the first administration of the study drug, he participated in any other drug clinical trials or is undergoing other clinical trials.\n9. Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint).\n10. The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study."}, 'identificationModule': {'nctId': 'NCT04189094', 'briefTitle': 'Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Chemoradiotherapy With or Without Sintilimab in Limited-stage Small Cell Lung Cancer: a Multicenter Prospective Randomized Phase II Trial', 'orgStudyIdInfo': {'id': 'IRB-2019-164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sintilimab + CRT arm', 'description': 'Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.', 'interventionNames': ['Drug: Sintilimab', 'Drug: Etoposide', 'Drug: Cisplatin', 'Radiation: radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CRT arm', 'description': 'Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).', 'interventionNames': ['Drug: Etoposide', 'Drug: Cisplatin', 'Radiation: radiotherapy']}], 'interventions': [{'name': 'Sintilimab', 'type': 'DRUG', 'description': 'Etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.', 'armGroupLabels': ['Sintilimab + CRT arm']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['VP-16'], 'description': 'Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.', 'armGroupLabels': ['CRT arm', 'Sintilimab + CRT arm']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['DDP'], 'description': 'cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.', 'armGroupLabels': ['CRT arm', 'Sintilimab + CRT arm']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).', 'armGroupLabels': ['CRT arm', 'Sintilimab + CRT arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ming Chen, MD. PhD.', 'role': 'CONTACT', 'email': 'chenming@zjcc.org.cn', 'phone': '86-571-88122199'}], 'overallOfficials': [{'name': 'Ming Chen, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Guangdong Medical University', 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}