Status:
UNKNOWN
Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 epiru...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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;
- ECOG PS 0\~2;
- Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10\*9 / L, neutrophil count ≥ 1.5 × 10\*9/ L; platelet count ≥ 100 ×10\*9/ L; hemoglobin ≥ 90 g / L;
- Adequate liver and renal function reserve: AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value;
- LVEF ≥ 55 %;
- Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.
Exclusion
- 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;
- d-MMR or MSI-H or Her-2 overexpression;
- Severe or uncontrolled infections or diabetes;
- History of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);
- Participated in other clinical trials within 4 weeks prior to the start of the study;
- Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study.
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04358341
Start Date
June 17 2020
End Date
December 1 2022
Last Update
August 24 2020
Active Locations (1)
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1
Jian Xiao
Guangzhou, Guangdong, China, 510655