drugset / Trial / NCT04358341
Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
For second-line chemotherapy for metastatic gastric cancer, single-agent irinotecan is the standard treatment. Anthracyclines are active but lack well designed investigations. The combination of epirubicin, fluorouracil and cisplatin (or oxaliplatin) are widely used in Europe. However, traditional anthracyclines are more cardiotoxic; and (Pegliposomal Doxorubicin) PLD, as a new liposome dosage form of doxorubicin, has better cardiac safety. Therefore, we designed this phase II trial with PLD and 5-Fu to compare irinotecan monotherapy in the second-line treatment.
Timeline
- Start
- 2020-06-17
- Primary completion
- 2022-06-01
- Completion
- 2022-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | PegLiposomal Doxorubicin | Unknown | 25 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |