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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    136
  • sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
Updated on 24 January 2021
platelet count
renal function
fluorouracil
doxorubicin
anthracyclines
oxaliplatin
neutrophil count
irinotecan
cancer chemotherapy
solid tumor
metastatic gastric cancer
epirubicin

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.

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 weeks until disease progression or untolerable toxicity. Efficacy will be assessed every 3 cycles and safety will be evaluated every cycle.

Details
Condition Gastropathy, Gastric Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Irinotecan, 5Fluorouracil, DOXOrubicin Liposome Injection
Clinical Study IdentifierNCT04358341
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 100 109/ 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 Criteria

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
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