Suspended
Phase II Study of Pegliposomal Doxorubicin and 5-fluorouracil Compared With Irinotecan as Second Line Therapy for Metastatic Gastric Cancer.
What is being tested
Irinotecan
+ DOXOrubicin Liposome Injection
+ 5fluorouracil
Drug
Who is being recruted
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
From 18 to 70 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: June 2020
Summary
Principal SponsorSixth Affiliated Hospital, Sun Yat-sen University
Study ContactXiaohui Zhai, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: June 17, 2020
Actual date on which the first participant was enrolled.Patients with metastatic gastric cancer failed to first-line therapy will be radomized to arm A with PLD and 5-Fu and arm B with irinotecan single agent therapy. Both regimens will be treated every 2 weeks until disease progression or untolerable toxicity. Efficacy will be assessed every 3 cycles and safety will be evaluated every cycle.
Official TitlePhase II Study of Pegliposomal Doxorubicin and 5-fluorouracil Compared With Irinotecan as Second Line Therapy for Metastatic Gastric Cancer.
Principal SponsorSixth Affiliated Hospital, Sun Yat-sen University
Study ContactXiaohui Zhai, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
136 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms
Criteria
9 inclusion criteria required to participate
Age 18-70 years old;
Metastatic gastric cancer progressed on first-line treatment;
Expected survival time ≥ 3 months;
At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1;
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9 exclusion criteria prevent from participating
Patients known to be allergic to active or other components of chemotherapeutic drugs;
Patients who have been treated with PLD or irinotecan in the past;
According to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy;
Those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort;
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active Comparator150 mg/m2 iv drip d1; Repeat every 14 days.
Group II
ExperimentalPegliposomal Doxorubicin: 25mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h d1; Repeat every 14 days.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center