Status:
UNKNOWN
Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The investigators reported previously that epigenetic activation of organic cation transporter (OCT2) by decitabine sensitizes RCC cells to oxaliplatin both in vitro and in xenografts. The objective o...
Detailed Description
CHUCAS-025 (Cancer Hospital, University of Chinese Academy of Sciences) is a phase II trial conducted at 3 investigative centres in the Zhejiang Province, China. Eligible patients are 18 to 75 years o...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age: 18 \~75 years old.
- Patients who are diagnosed pathologically with relapsed/metastatic renal cell carcinoma have a disease progression on standard of care.
- Performance status: Eastern Cooperative Oncology Group performance status ≦2.
- Life expectancy more than 3 months.
- Patients have adequate organ function, accord with following criteria: A. blood routine: Hemoglobin≥90g/L, absolute neutrophil count≥1.5×109/L, platelet count ≥ 80×109/L; B. Biochemical tests: total bilirubin is less than 1.5 times upper limit of normal, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times upper limit of normal; C. creatinine less than 1.25 times upper limit of normal.
- Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women.
- Patients agree to receive treatment with epigenetic drugs.
- Participant sign an institutional review board-approved, protocol-specific informed consent form in accordance with institutional guidelines.
- Exclude criteria:
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
- Organs failure.
- ECOG \>2.
- Serious/active infection.
- Autoimmune disorders or immunodeficiency diseases.
- Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids.
- Uncontrolled hypertension.
- Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia.
- Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) \<50%.
- Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy.
- Unhealed wounds, or fractures.
- With a history of psychotropic drug abuse or mental disorders.
- Prior systemic therapies with any antitumor agents within 4 weeks.
- With other uncurable cancers simultaneously.
Exclusion
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04049344
Start Date
August 15 2019
End Date
December 31 2021
Last Update
August 8 2019
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022