Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment
试验速览
- 阶段
- 2 期
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- One-year survival rate
研究概览
简要总结
We conduct the clinical trial to further explore the efficacy and safety of Apatinib combined with chemotherapy in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.
详细描述
Esophageal cancer is one of the most common malignant tumor and esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma in China. Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor. New treatments were needed. Apatinib, which was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer, is a small molecule tyrosine kinase inhibitor. It competes with intracellular VEGFR-2's ATP binding sites highly and selectively, thereby blocking downstream signaling to achieve the goal of inhibiting neovascularization in tumor tissue. We have observed in clinical practice that some patients with esophageal squamous cell carcinoma have benefited from the treatment of apatinib. So we conduct a phase II clinical trial to explore the efficacy and safety of Apatinib combined with chemotherapy (platinum and fluorouracil) in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.
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
- Single (Outcomes Assessor)
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
- •1.Male or female patients, age:≥18 years old.
- •2.Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
- •3.Patients who undergo local or recurrent metastases after surgery and / or radiotherapy and chemotherapy,at least one measurable lesion(tumor lesions CT scan length ≥ 10 mm,lymph node lesions CT scan short diameter ≥ 15 mm,scan layer thickness is not greater than 6 mm).
- •4.The ECOG physical status score: 0 to
- •5.Expected survival ≥ 3 months.
- •6.Subjects received other treatment damage have been restored, which received nitroso or mitomycin interval ≥ 6 weeks; to accept other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed;
- •7.The main organs function properly:
- •blood routine examination standards to be met (14 days without blood transfusion and blood products):
- •ANC≥1.5×109/L;
- •PLT≥80×109/L;
- •biochemical tests to meet the following criteria:
- •TBIL<1.5×ULN;
- •ALT and AST<2.5×ULN, and <5×ULN for patients with liver metastases
- •Serum Cr≤1.5×ULN or endogenous creatinine clearance> 45ml/min (Cockcroft-Gault formula);
- •8.The women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use the appropriate method at 8 weeks after the trial and the last given test contraception.For the man, consent should be given to appropriate contraception or surgical sterilization 8 weeks after the trial and at the last time the test drug was given;
- •9.Patients should be voluntary to the trial and provide with signed informed consent
排除标准
- •1.Pregnant or lactating women;
- •2.Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with myocardial infarction or myocardial infarction, arrhythmia and grade II heart Incomplete function;
- •3.Have a significant impact on oral drug absorption factors, such as unable to swallow, chronic diarrhea and intestinal obstruction;
- •4.Coagulation dysfunction(INR>1.5 or prothrombin time (PT)>ULN + 4 seconds or APTT>1.5×ULN),with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
- •5.with a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + + above), 6 months of history of gastrointestinal bleeding;
- •6.Central nervous system metastasis with symptoms;
- •7.The investigator judged other circumstances that will affect the conduct of the study and the outcome of the study
研究组 & 干预措施
Apatinib with Chemotherapy
Apatinib with Chemotherapy(Fluorouracil and platinum)，patients will receive Apatinib at 500mg/times,oral one times daily for 28 days.the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
干预措施: Apatinib (Drug)
Apatinib with Chemotherapy
Apatinib with Chemotherapy(Fluorouracil and platinum)，patients will receive Apatinib at 500mg/times,oral one times daily for 28 days.the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
干预措施: fluorouracil and platinum (Drug)
Chemotherapy
Chemotherapy (Fluorouracil and platinum)，the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients.
干预措施: fluorouracil and platinum (Drug)
结局指标
主要结局
One-year survival rate
时间窗: 12 months
The probability of survival in one year
次要结局
- Progress free survival（PFS）(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Incidence of Treatment-Emergent Adverse Events(Each follow up visit, assessed up to 12 months)
- Quality of life using EORTC QLQ C30 - scale(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)