Clinical trial NCT04358341: Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer
Official title: Phase II Study of Pegliposomal Doxorubicin and 5-fluorouracil Compared With Irinotecan as Second Line Therapy for Metastatic Gastric Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Pegliposomal Doxorubicin
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old;
2. Metastatic gastric cancer progressed on first-line treatment;
3. Expected survival time ≥ 3 months;
4. At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1;
5. ECOG PS 0\~2;
6. 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;
7. 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;
8. LVEF ≥ 55 %;
9. Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.

Exclusion Criteria:

1. Patients known to be allergic to active or other components of chemotherapeutic drugs;
2. Patients who have been treated with PLD or irinotecan in the past;
3. According to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy;
4. Those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort;
5. d-MMR or MSI-H or Her-2 overexpression;
6. Severe or uncontrolled infections or diabetes;
7. History of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);
8. Participated in other clinical trials within 4 weeks prior to the start of the study;
9. Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study.

Primary outcomes:
measure: Disease control rate (DCR)
timeFrame: 24 weeks
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 24 weeks
measure: Progression-Free Survival (PFS)
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Treatment associated toxicities
timeFrame: 2 years
measure: EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jian Xiao
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jian Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References: