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SRS Sequential Sindilimab in Brain Metastasis of NSLSC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180501
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaorong Dong, Wuhan Union Hospital, China

Brief Summary:
A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab

Condition or disease Intervention/treatment Phase
NSCLC Stage IV Brain Metastases SRS Sintilimab Combination Product: SRS sequential sintilimab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study on the Treatment of Advanced Non-small Cell Lung Cancer With Brain Metastasis by SRS Sequential Sintilimab
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SRS sequential sintilimab Combination Product: SRS sequential sintilimab
The subjects first received a targeted radiotherapy of SRS, and started the treatment of sintilimab per 3 weeks within 35 days after SRS.




Primary Outcome Measures :
  1. iPFSof NSCLC patients receiving SRS sequential sintilimab [ Time Frame: 1 year ]
    From the beginning of treatment to the end of follow-up study, when the longest diameter of brain metastases treated by SRS was more than 30% smaller than the baseline level at any time of efficacy evaluation, the objective remission of the lesions was achieved. The time from the objective remission to the next progress of the intracranial lesions was recorded as the intracranial progression-free survival(iPFS).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non-small cell lung cancer patients with less than brain metastases
  • Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment
  • Patients who have not received intracranial local treatment before

Exclusion Criteria:

  • Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds
  • Patients with hemorrhage in intracranial metastasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180501


Contacts
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Contact: xiaorong dong, Dr 15071116896 zrg27@163.com

Locations
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China, Hubei
Union hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: dong xiaorong, Dr         
Sponsors and Collaborators
Xiaorong Dong

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Responsible Party: Xiaorong Dong, Professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04180501    
Other Study ID Numbers: sintilimab
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Brain Diseases
Nervous System Diseases