Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC
NCT ID: NCT04189094
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2020-01-01
2023-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sintilimab + CRT arm
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.
Sintilimab
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.
Etoposide
Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
Cisplatin
cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
radiotherapy
Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).
CRT arm
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).
Etoposide
Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
Cisplatin
cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
radiotherapy
Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).
Interventions
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Sintilimab
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.
Etoposide
Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
Cisplatin
cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
radiotherapy
Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
3. Patients should be ≥ 18 years old.
4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
6. With weight loss no more than 10% within 6 months before diagnosis.
7. Informed consent must be signed.
Exclusion Criteria
2. 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.);
3. Any disease or condition contraindicated by radiotherapy or chemotherapy;
4. Malignant pleural effusion and pericardial effusion;
5. Pregnant and lactating women;
6. History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia;
7. Received live vaccination within 28 days before the first administration of the study drug;
8. 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.
9. Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
10. 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.
18 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Affiliated Hospital of Guangdong Medical University
OTHER
First People's Hospital of Foshan
OTHER
Zhejiang Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Ming Chen, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)
Central Contacts
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Other Identifiers
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IRB-2019-164
Identifier Type: -
Identifier Source: org_study_id