Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
NCT ID: NCT06536868
Last Updated: 2024-08-05
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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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-08-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICI+EC/EP+TRT
Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin
Tislelizumab
Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).
Etoposide
Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).
Carboplatin or Cisplatin
Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).
Thoracic radiotherapy
IMRT 30-45Gy/10-15f
Interventions
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Tislelizumab
Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).
Etoposide
Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).
Carboplatin or Cisplatin
Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).
Thoracic radiotherapy
IMRT 30-45Gy/10-15f
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and severe primary diseases of the heart, brain, liver, or kidneys;
* Uncontrolled active infections;
* Known or suspected allergies to the study medication and its excipients;
* Female patients who are pregnant or breastfeeding, or women of childbearing potential with a positive baseline pregnancy test;
* Prior use of antitumor treatment targeting the PD-(L)1 pathway.
18 Years
80 Years
ALL
No
Sponsors
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Second Hospital of Shanxi Medical University
OTHER
Responsible Party
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Gang Jin
Dr.
Principal Investigators
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Gang Jin, Dr.
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Shanxi Medical University
Locations
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Jincheng General Hospital
Jincheng, Shanxi, China
Jinzhong third people's hospital
Jinzhong, Shanxi, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
TISCO General Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Xueqin Li, Dr.
Role: primary
Qian Wu, Dr.
Role: primary
Gang Jin, Dr.
Role: primary
Huijing Feng, Dr.
Role: primary
Jinyang Bai, Dr.
Role: primary
Weihua Jia, Dr.
Role: primary
Other Identifiers
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[2024] YX No. 274
Identifier Type: -
Identifier Source: org_study_id
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