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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT04358341
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    150 mg/m2 ivdrip every 14 days
  • DOXOrubicin Liposome Injection — DRUG
    25 mg/m2 ivdrip every 14 days
  • 5fluorouracil — DRUG
    400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days

Study Details

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.

Key Dates

Start date
Jun 17, 2020
Status verified
Aug 2020
Primary completion
Jun 1, 2022
Completion
Dec 1, 2022

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Irinotecan alone
    150 mg/m2 iv drip d1; Repeat every 14 days.
  • Experimental: Pegliposomal Doxorubicin and 5-FU
    Pegliposomal Doxorubicin: 25mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h d1; Repeat every 14 days.

Primary Outcome Measure

Disease control rate (DCR) [ Time Frame: 24 weeks ]

Central Contacts

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