Status:
UNKNOWN
Effect of Combination Therapy on SCLC After Initial Treatment Failure
Lead Sponsor:
First Affiliated Hospital of Harbin Medical University
Conditions:
Small-cell Lung Cancer
Eligibility:
All Genders
18-80 years
Brief Summary
SCLC patients after initial treatment failure are treated with SBRT and low-dose radiotherapy concurrent with PARP inhibitors + temozolomide +PD-1/PD-L1 inhibitors for two cycles at least, then PARP i...
Detailed Description
SCLC is easy to relapse and drug resistance soon after initial treatment , although radiotherapy and chemotherapy is sensitive at first treatment. Topotecan monotherapy is recommended in the NCCN guid...
Eligibility Criteria
Inclusion
- Age ≥18 years old, ≤80 years old, expected survival ≥3 months;Pathologically confirmed SCLC with recurrence and metastasis after initial treatment;KPS score ≥70 points;Satisfied the following laboratory diagnostic indicators: hemoglobin ≥110g/L, leukocyte 4.0-10.0×109/L, neutrophils 2.0-7.5×109/L, platelet ≥100×109/L;Creatinine ≤ upper normal limit (UNL);ALT and AST≤2.5×UNL, alkaline phosphatase (ALP) ≤5×UNL, total bilirubin (TBIL) ≤ UNL;Signed informed consent.
- \-
Exclusion
- Pregnant or lactating women;
- Secondary tumor;
- HIV carriers;
- Serious medical diseases such as heart and lung;
- Patients with uncontrollable mental history, unable to cooperate with treatment;
- Autoimmune system disease, symptomatic interstitial lung disease;
- Patients with active infection, chronic infection, acute infection, etc., and body inflammation;
- Patients who had used hormones or antibiotics 1 month prior to treatment. -
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04790955
Start Date
March 1 2021
End Date
March 1 2024
Last Update
March 10 2021
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