Status:
UNKNOWN
Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Collaborating Sponsors:
Chinese Academy of Sciences
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This Phase II study was designed to evaluate the safety and efficacy of albumin paclitaxel in combination with simvastatin compared with treatment with albumin paclitaxel alone in ES-SCLC patients rel...
Detailed Description
PRIMARY OBJECTIVES: I.To assess disease control rate (DCR) after treatment. SECONDARY OBJECTIVES: I.To assess best overall response rate (ORR) after treatment. II.To evaluate the progression-free s...
Eligibility Criteria
Inclusion
- Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and be able to complete all test procedures.
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system).
- No patients with resectable or radical radiotherapy lung cancer.
- Patient must have no Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) rearrangement, or ROS proto-oncogene 1 , receptor tyrosine kinase(ROS1) rearrangement.
- Patient must be at least resistant to the first-line chemotherapy.
- Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Patients can tolerate chemotherapy.
Exclusion
- Unclear diagnosis of SCLC.
- Resectable or radical radiotherapy SCLC.
- Contraindicated chemotherapy.
- Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.
- Positive test result for human immunodeficiency virus (HIV).
- Positive test result for active tuberculosis.
- Live vaccine was administered within 28 days of initial administration. Inactivated viral vaccines for seasonal influenza are allowed, except for live attenuated intranasal vaccines.
- Pregnant or lactating women.
- A history of psychotropic substance abuse, drug abuse, or alcoholism.
- Other factors assessed by the sponsors.
Key Trial Info
Start Date :
July 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04698941
Start Date
July 25 2021
End Date
December 30 2022
Last Update
July 29 2021
Active Locations (2)
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1
CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, China, 200031
2
Shanghai pulmonary hospital, Tongji University
Shanghai, Shanghai Municipality, China, 200433