Last updated: December 16, 2020
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Not Recruiting
Phase
2
Condition
Gliomas
Astrocytoma
Treatment
N/AClinical Study ID
NCT04674527
SAHZJU-RCT-ELEMENE
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years; Male or Female.
- Relapsed/refractory disease confirmed by radiographic evidence after standard therapy.
- KPS ≥ 60
- ≥ 8 weeks after completion of front-line radiation therapy
- ≥ 6 weeks after completion of nitrourea chemotherapy
- ≥ 14 days after completion of Temozolomide or other chemotherapy
- 2 weeks of wash-out time after completion of targeted therapy with related adverseevents (AE) on baseline
- White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
- Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
- Patients must be able to understand the investigational nature of the study andprovide informed consent.
Exclusion
Exclusion Criteria:
- Those who are allergic constitution, or have contraindications to CT and MRI1 contrastagents.
- Those who plan to receive any other anti-tumor treatment during the trial.
- Combined with serious primary diseases of cardiovascular, liver and kidney, and liverfunction (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
- Patients with other malignant tumors.
- Those with active infections, etc.
- Suspected or confirmed a history of alcohol and drug abuse.
- Psychiatric illness, intellectual and language disabilities that compromise theinformed consent process, at the discretion of the investigator.
- Women who are pregnant or nursing.
- Women of childbearing age who refuse to contraception.
- Active participation in another clinical treatment trials.
- According to the judgment of the investigator, other conditions that the plan cannotbe followed.
Study Design
Total Participants: 30
Study Start date:
June 01, 2021
Estimated Completion Date:
June 01, 2023
Study Description
Connect with a study center
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang 310009
ChinaSite Not Available

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