NCT03975036Unknown2 期
Exploratory Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Hydrochloride Combined With Pd-1 Antibody: An Open-Label, Single-center, Single-arm Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 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
The main objective was to evaluate the safety and efficacy of anlotinib hydrochloride combined with pd-1 antibody second-line and above in the treatment of advanced solid tumors
详细描述
To observe the beneficial population and adverse reactions of anlotinib hydrochloride combined with pd-1 in the treatment of patients with advanced solid tumor, and to explore the safe and effective drug treatment dose in the combined program, so that more patients with advanced tumor with poor prognosis can benefit from the combined program
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed the informed consent form prior to patient entry.
- •There is at least one measurable lesion in the pathologically diagnosed advanced solid tumor, including non-small cell lung cancer, liver cancer, gastric cancer, colorectal cancer, pancreatic cancer, soft tissue sarcoma, malignant melanoma, gallbladder cancer, esophageal cancer, ovarian cancer, endometrial cancer and breast cancer
- •≥ 18 and ≤ 70 years of age.
- •Eastern Cooperative Oncology Group(ECOG) performance status 0 or
- •Life expectancy of more than 3 months.
- •Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN, Cr clearance ≥ 60 mL/min;Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
- •Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.
排除标准
- •uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms).
- •Patients previously treated with anticancer therapies also have a Toxicity Level> 1 in NCI CTCAE.
- •A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
- •Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months; (3) ) For fecal occult blood (+) must be gastroscopy, clear whether the existence of gastrointestinal organic diseases.
- •Coagulation dysfunction (INR> 1.5, PT> ULN + 4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
- •Long-term, unhealed wounds or fractures.
- •Active bleeding, within 30 days after major surgery.
- •Intracranial metastasis.
- •Pregnant or lactating women.
- •Cytotoxic drug treatment, radiotherapy within 3 weeks after treatment; had taken two or more targeted drugs, or into the group before the other three months have been taking other targeted drugs.
- •Other malignant tumors in the past 3 years.
- •The investigators believe there is any condition that may harm the subject or result in the subject's inability to meet or perform the research requirements.
- •Huge metastasis / recurrence (tumor diameter> 5 cm)。
- •Malignant pleural effusion or ascites, causing NCI CTCAE grading 2 or more people with dyspnea.
- •Any allergy to apatinib should be excluded.
- •Severe liver and kidney dysfunction (grade 4) patients should be excluded.
- •Persons with a history of substance abuse who can not be abdicated or have mental disorders.
- •According to the judgment of the researcher, there is a concomitant disease that seriously endangers the patient's safety or affects the patient in completing the study.
研究组 & 干预措施
Anlotinib&pd-1 antibody
Experimental
Anlotinib 10mg/d,q.d.,p.o.&pd-1 antibody 200mg/d.q.3w.d.l.v
干预措施: Anlotinib (Drug)
Anlotinib&pd-1 antibody
Experimental
Anlotinib 10mg/d,q.d.,p.o.&pd-1 antibody 200mg/d.q.3w.d.l.v
干预措施: pd-1 antibody (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to 2 year
From date of randomization until the date of first documented progression or date of death from any cause
次要结局
- Overall survival(OS)(up to 2 year)
- Objective Response Rate (ORR)(up to 1 year)
- Disease Control Rate (DCR)(up to 1 year)
研究者
研究点 (1)
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