NCT05705635招募中2 期
A Multicenter, Randomized, Controlled Phase II Clinical Study of Comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in Second-line or Above Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-Free-Survival (PFS)
研究概览
简要总结
This trial is a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
详细描述
One hundred patients with locally advanced or metastatic gastric adenocarcinoma or gastric esophageal junction adenocarcinoma will be randomly assigned to the test group or the control group. All patients will receive Docetaxel for injection (Albumin-bound) or Taxotere for treatment until disease progression. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 (inclusive) (Whichever is on the day of signing the informed consent form).
- •Willing to sign the informed consent form, willing and able to follow the program to accept visits, treatment and laboratory tests.
- •Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.
- •Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction after receiving at least first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy).
- •Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment.
- •Adequate main organ function.
- •Eastern Cooperative Oncology Group (ECOG) score 0-
- •Expected lifetime≥ 3 months.
- •Female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to randomization; patients must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women are not breastfeeding; male patients must agree to contraception and refuse sperm donation.
- •At least one assessable lesion according to RECIST V1.1; The area should not have received radiotherapy in the past, or there is evidence that the lesion has made definite progress after radiotherapy.
排除标准
- •Other active malignant tumors in the first 5 years of randomization.
- •Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 7 days before randomization.
- •Patients with central nervous system metastasis.
- •Patients whose previous medical history shows dMMR/MSI-H and who have not received immunotherapy in the past are not suitable for enrollment, and those whose dMMR/MSI status is unknown need to clarify the status before enrolment.
- •Patients who have used paclitaxel/docetaxel in the past (except patients with disease progression more than one year after neoadjuvant/adjuvant treatment with paclitaxel/docetaxel).
- •History of serious cardiovascular disease within 6 months before randomization.
- •History of gastrointestinal perforation and/or fistula within 6 months before randomization.
- •Hypertension with poor control during the screening period.
- •Patients with active hepatitis B, hepatitis C or HIV.
- •Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy.
- •Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization.
- •Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0).
- •Major organ surgery (except puncture biopsy) within 28 days before randomization.
- •Have received chemotherapy, radiotherapy, targeted therapy, immunotherapy or other anti-tumor treatment of clinical research drugs within 28 days before randomization.
- •Have received traditional Chinese medicine with anti-tumor indications within 14 days before randomization.
- •Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization.
- •Allergic to and / or contraindication to albumin or docetaxel.
- •Known allergy and/or contraindication to glucocorticoids.
- •Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence / alcohol dependence.
- •Other situations that the researcher thinks are not suitable for participating in this study.
- •Patients participated in another clinical study at the same time, unless it is an observational (non intervention) clinical study or is in the follow-up period of an intervention study.
研究组 & 干预措施
Docetaxel for Injection (Albumin-bound)
Experimental
Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks.
干预措施: Docetaxel for injection (Albumin-bound) (Drug)
Taxotere
Active Comparator
Taxotere will be administrated by intravenous infusion once every 3 weeks.
干预措施: Taxotere (Drug)
结局指标
主要结局
Progression-Free-Survival (PFS)
时间窗: Up to approximately 2 years
The duration is from the randomized time to disease progression or death due to any reason.
次要结局
- Overall response rate (ORR)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Incidence of AE and SAE(Up to approximately 2 years)
- Duration of Response (DoR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
研究者
研究点 (1)
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