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Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

NCT04189094 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-12-06

No results posted yet for this study

Summary

The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.

Conditions

  • Small Cell Lung Cancer Limited Stage

Interventions

DRUG

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.

DRUG

Etoposide

Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.

DRUG

Cisplatin

cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.

RADIATION

radiotherapy

Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Affiliated Hospital of Guangdong Medical University

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Ming Chen, MD. PhD. · Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-07-01
Completion
2023-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189094 on ClinicalTrials.gov