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Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): an Multicenter, Single Arm Prospective Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays), male or female, at the time of signing the informed consent form;

• Confirmed small cell lung cancer of extensive stage by histology or cytology;

• At least one measurable lesion by imaging studies (according to RECIST 1.1) with a long diameter of ≥10 mm as examined by spiral CT or MRI;

• Within 3 days prior to treatment, an ECOG score of 0 to 1;

• No prior antitumor treatment for extensive stage disease (if the patient has previously received chemotherapy and/or radiotherapy in the limited stage of SCLC, the treatment intent must have been curative, and there must be at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive stage SCLC);

• Expected life span of ≥3 months;

• Good function of vital organs;

• The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.

Locations
Other Locations
China
Jincheng General Hospital
RECRUITING
Jincheng
Jinzhong third people's hospital
RECRUITING
Jinzhong
Second Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Shanxi Hospital of Traditional Chinese Medicine
RECRUITING
Taiyuan
TISCO General Hospital
RECRUITING
Taiyuan
Contact Information
Primary
Gang Jin, Dr.
jingang2018@sina.com
+86 351 3365422
Backup
Chen Zhang
jingang2018@sina.com
+86 351 3365422
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Experimental: ICI+EC/EP+TRT
Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin
Sponsors
Leads: Second Hospital of Shanxi Medical University

This content was sourced from clinicaltrials.gov

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