NCT05029453Unknown4 期
A Prospective, Multicenter, Randomized Controlled Study of Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression Free Survival [PFS]
研究概览
简要总结
The study is a multicenter, open-label, randomized controlled clinical study. The purpose of the study is to evaluate the efficacy and safety of apatinib combined with chemotherapy versus chemotherapy in second-line gastric cancer receiving prior anti-PD-1 therapy.
详细描述
60 patients who meet the inclusion criteria will receive apatinib combine with chemotherapy or chemotherapy until the disease progresses or intolerable.
Apatinib: initial dose: 500mg,oral,once a day, after meal (try to take the medicine at the same time each day)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old, Female or Male;
- •Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
- •Failure or intolerance of first-line chemotherapy which requires that the first-line chemotherapy regimen include the scheme based on anti-PD-1 drugs for no less than 2 months (Definition of treatment failure: intolerence of toxic side effects; disease progression during treatment; Or recurrence after the end of treatment.) Note: (1)The treatment of each line advanced disease includes one or more drugs with a medication time ≥ 1 cycle. (2) Early adjuvant/neo-adjuvant therapy is allowed. If recurrence occurs during adjuvant/neoadjuvant therapy or within ≤24 weeks after completion, adjuvant/neoadjuvant therapy is considered to be a first-line pre-systemic chemotherapy for advanced disease. (3) Early-stage immunotherapy, combined chemotherapy or combined targeted drugs are allowed (except for VEGFR inhibitors).
- •Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria
- •ECOG performance status 0-
- •An expected survival of > 12 weeks.
- •Has adequate sufficient organ and bone marrow functions.
- •Patients whose adverse events caused by previous treatment have recovered to <= CTCAE 1 degree; And the interval between receiving nitroso or mitomycin ≥6 weeks; Receiving other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has healed completely.
- •Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug
- •Patients have agreed and signed the informed consent. Willingness and able to follow the planned visit, research treatment, laboratory examination and other test procedures.
排除标准
- •It is known that it's allergic to any test drug and its excipients.
- •Previously received anti-angiogenic therapy, such as Ramucirumab and apatinib.
- •patients with uncontrolled large amount of exudate [chest, pericardium, abdominal cavity]
- •Patients with partial or complete gastrointestinal obstruction.
- •Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- •Patients with uncontrolled clinical symptoms or diseases of the heart.
- •In the first 3 months of the study, patients who had significant clinical bleeding symptoms or had definite bleeding tendency; History of gastrointestinal perforation and/or fistulae within 6 months prior to medications.
- •Long term use of aspirin, clopidogrel and other antiplatelet drugs, or warfarin and other anticoagulants;
- •Received other therapy within 4 weeks.
- •The patients who received systemic treatment with Chinese herbal medicine or immunomodulatory drugs
- •According to the research's judgement, there are patients who seriously endanger the safety of patients or affect the patients who complete.(such as uncontrolled hypertension、diabetes、thyroid disease, etc)
- •The patient has a serious or non healing wound or peptic ulcer or bone fracture;
- •A patient with other malignancies within 3 years.
- •patients whose adverse events (except hair loss) caused by previous treatment have not recovered to <= CTCAE 1 degree;
- •The researchers considered unsuitable for inclusion.
研究组 & 干预措施
Experimental Group
Experimental
apatinib combine with chemotherapy. Apatinib: initial dose: 500mg,oral,once a day, after meal ( try to take the medicine at the same time each day) Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression Free Survival [PFS]
时间窗: 36 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
次要结局
- Duration of response [DoR](1year)
- overall survival [OS](3year)
- disease control rate [DCR](1year)
- Objective tumor response rate [ORR](1year)
- Adverse Events [AEs](1year)
研究者
Tao Zhang
Chief of gastrointestinal oncology
Wuhan Union Hospital, China
研究点 (1)
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