NCT07547592尚未招募2 期
Phase II, Randomized Trial of Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Previously Treated Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 92
- 主要终点
- Overall Response Rate, ORR
研究概览
简要总结
Arm1- bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion.
Arm2- On Day 1 of each 21-day cycle, gemcitabine will be administered first, followed by docetaxel as an intravenous infusion. On Day 8, gemcitabine and docetaxel will be administered as intravenous infusions.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), liposarcoma, or angiosarcoma with 1-2 prior chemotherapy
- •: neoadjuvnat or adjuvant chemotherapy is counted as one regimen
- •Age ≥19 years, <80 years
- •ECOG performance status of 0-1
- •Has at least 1 measurable lesion (as defined by RECIST v1.1).
- •Has adequate organ function defined by the following criteria:
- •Hb ≥ 9.0 g/dL
- •Absolute neutrophil count (ANC) ≥ 1500 /µL
- •Platelet ≥ 75,000/ µL
- •Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis)
- •Serum Creatinine: ≥ 50 mL/min
- •AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
- •Alkaline Phosphatase (ALP): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis)
- •Female patient of childbearing potential has a negative serum or urine pregnancy test for β-hCG
- •Able to provide written informed consent and comply with the protocol requirements
排除标准
- •Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study
- •More than 3 prior cytotoxic agents
- •previously received treatment with bevacizumab, gemcitabine, or docetaxel
- •Unresolved toxicities from prior anticancer therapy ≥ Grade 2 according to NCI CTCAE, excluding alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria
- •Major surgery within 28 days prior to randomization.
- •Active or prior documented autoimmune or inflammatory disorders
- •Unstable cardiovascular disease
- •Has an active infection requiring parenteral treatment
- •History of another primary malignancy
- •Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
- •Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
- •Pre-existing interstitial lung disease (ILD)
研究组 & 干预措施
Bev + Gem + Doc
Experimental
bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion.
干预措施: Bev + Gem + Doc (Drug)
Gem + Doc
Active Comparator
- Gemcitabine 1,000 mg/m² IV on Days 1 and 8 of each 21-day cycle (administered over 30 minutes)
- Docetaxel 35 mg/m² IV on Days 1 and 8 of each 21-day cycle (administered over 60 minutes) On Day 1 of each 21-day cycle, gemcitabine will be administered first, followed by docetaxel as an intravenous infusion. On Day 8, gemcitabine and docetaxel will be administered as intravenous infusions.
干预措施: Gem + Doc (Drug)
结局指标
主要结局
Overall Response Rate, ORR
时间窗: 2 year
Overall response rate (ORR) based on RECIST version 1.1
次要结局
- Progression-free survival (PFS)(2 year)
- Overall survival (OS)(2 year)
- Safety profile(2 year)
研究者
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