Brain Metastases Clinical Trial
Official title:
A Phase II Study on the Treatment of Advanced Non-small Cell Lung Cancer With Brain Metastasis by SRS Sequential Sintilimab
A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Union hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Xiaorong Dong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | iPFSof NSCLC patients receiving SRS sequential sintilimab | 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). | 1 year |
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