Phase II Study of Pegliposomal Doxorubicin and 5-fluorouracil Compared With Irinotecan as Second Line Therapy for Metastatic Gastric Cancer.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Disease control rate (DCR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Irinotecan alone
150 mg/m2 iv drip d1; Repeat every 14 days.
干预措施: Irinotecan (Drug)
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.
干预措施: DOXOrubicin Liposome Injection (Drug)
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.
干预措施: 5fluorouracil (Drug)
结局指标
主要结局
Disease control rate (DCR)
时间窗: 24 weeks
Percentage of subjects with tumor shrinkage reaching complete response (CR), partial response (PR) and disease stabilization (SD).
次要结局
- Objective response rate (ORR)(24 weeks)
- Progression-Free Survival (PFS)(1 year)
- Overall Survival (OS)(2 years)
- Treatment associated toxicities(2 years)
- EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores(2 years)
研究者
Jian Xiao
Asso. Professor
Sixth Affiliated Hospital, Sun Yat-sen University