Clinical trial · Interventional
Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma
Phase II Multicenter Open-Label Single-Arm Study of Decitabine Combined With Oxaliplatin in Patients With Relapsed/Metastatic Renal Cell Carcinoma
NCT04049344CI-TRIAL-00039967unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 of this phase II clinical trial is to investigate the efficacy and safety of sequential combination therapy with decitabine and oxaliplatin in patients with relapsed/metastatic renal cell carcinoma who progressed on standard of care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine; Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination of decitabine with oxaliplatin treatment
- description
- Patients receive Decitabine 10 mg/day for 5 consecutive days (d1-5) plus Oxaliplatin 75mg/m2 2-week-cycle (d6, d20) within 4 weeks. One cycle is defined as 4 weeks of treatment and total of 6 cycles are designed for patients.
- interventionNames
- Drug: Decitabine; Oxaliplatin
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- Six months after randomization
- description
- Progression free survival is defined as the time from randomization to first documented RECIST-defined tumor progression or death from any cause. Disease assessments are performed with the use of computed tomography or magnetic resonance imaging at baseline, every 8 weeks for the first year, and then every 12 weeks until disease progression or discontinuation of treatment. Imaging data were evaluated by the investigator to assess tumor response (according to RECIST version).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria 1. Age: 18 \~75 years old. 2. Patients who are diagnosed pathologically with relapsed/metastatic renal cell carcinoma have a disease progression on standard of care. 3. Performance status: Eastern Cooperative Oncology Group performance status ≦2. 4. Life expectancy more than 3 months. 5. 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. 6. Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women. 7. Patients agree to receive treatment with epigenetic drugs. 8. Participant sign an institutional review board-approved, protocol-specific informed consent form in accordance with institutional guidelines. Exclude criteria: 1. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. 2. Organs failure. 3. ECOG \>2. 4. Serious/active infection. 5. Autoimmune disorders or immunodeficiency diseases. 6. Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids. 7. Uncontrolled hypertension. 8. Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia. 9. Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) \<50%. 10. Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy. 11. Unhealed wounds, or fractures. 12. With a history of psychotropic drug abuse or mental disorders. 13. Prior systemic therapies with any antitumor agents within 4 weeks. 14. With other uncurable cancers simultaneously.
References
Publications (0)
Data not yet available
No reference posted for this study.