drugset / Trial / NCT04358341

Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer

NCT04358341 ↗

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

EvaluationDrugModalityDoseRoute
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

Indications