NCT04958993终止1 期
A Phase I/II Clinical Study of Anlotinib Hydrochloride Capsule Combined With Concurrent Chemoradiotherapy in the Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Shandong Cancer Hospital and Institute1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年11月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Progress free survival (PFS) for phase Ⅱ
研究概览
简要总结
This is a phase I/II exploratory study to evaluate the efficacy and safety of anlotinib combined with concurrent chemoradiotherapy in the treatment of surgically unresectable stage III non-small cell lung cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients volunteered to participate in this study and signed the informed consent;
- •Locally advanced (IIIA/IIIC) non-small cell lung cancer patients diagnosed by pathology as newly diagnosed unresectable, inoperable or refused surgery (difficult patients should be evaluated by thoracic multidisciplinary assessment for potential enrollment); .
- •Ages 18-75, regardless of gender;
- •ECOG score: 0-1;
- •Expected survival over 3 months;
- •Function of major organs within 7 days prior to treatment meets the following criteria:
- •A. Standard of blood routine examination (without blood transfusion within 14 days) :
- •I. Hemoglobin (HB) ≥100 g/L; II. WBC ≥3.0×109/L; Iii. Platelet (PLT) ≥100×109/L.
- •B. Biochemical examination shall meet the following standards:
- •I. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN); II. AST≤2.5×ULN of alanine aminotransferase (ALT) and aspartate aminotransferase (ASpartate), if accompanied by liver metastasis, ALT and AST≤5×ULN; III. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCr)≥60ml/min; C. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower normal limit (50%); D. Pulmonary function assessment: FEV1≥1.45 l/s.
- •Patients of childbearing age (including female and female partners of male patients) must take effective birth control measures
排除标准
- •Patients who have previously used anlotinib hydrochloride capsules;
- •Small cell lung cancer (including mixed small cell and non-small cell cancers);
- •Lung squamous cell carcinoma with empty cavity, or non-small cell lung cancer with hemoptysis (> 20ml/day);
- •Patients with other malignant tumors other than NSCLC within 5 years before the start of treatment in this study (except those with simple surgical resection and disease-free survival for at least 5 consecutive years, cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor);
- •Systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors and immunotherapy, is planned within 4 weeks before enrollment or during the medication period of this study.In addition to thymosin, lentinan and other immunomodulator treatment.
- •Unmitigated toxicity due to any previous treatment above CTC AE level 1, excluding hair loss;
- •Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- •Accompanied by pleural effusion or ascites, causing respiratory syndrome (≥CTC AE level 2 dyspnea);
- •Patients with any severe and/or uncontrolled disease, including: A) Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); B) Having grade I or above myocardial ischemia or infarction, arrhythmia (including QTc ≥480ms), and grade 2 or above congestive heart failure (New York Heart Association (NYHA) classification); C) Active or uncontrolled severe infection (≥CTC AE level 2 infection); D) Antiviral treatment for cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; E) Renal failure requires hemodialysis or peritoneal dialysis; F) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; G) poor control of diabetes mellitus (FBG) > 10mmol/L; H) urine routine indicated urinary protein ≥++, and confirmed 24-hour quantitative urinary protein > 1.0g; I) patients with epileptic seizures requiring treatment; J) Patients with gastric ulcer
- •Receive major surgical treatment, open biopsy or significant traumatic injury within 28 days before grouping;
- •Patients whose tumors have invaded important blood vessels according to imaging findings or whose tumors are likely to invade important blood vessels during the follow-up study according to the judgment of the researchers, resulting in fatal massive hemorrhage;
- •Patients with any physical signs or history of bleeding, regardless of severity;Patients with any bleeding or bleeding event ≥CTCAE level 3 within 4 weeks prior to enrollment have unhealed wounds, ulcers or fractures;
- •Occurrence of ARTERIAL/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks), deep venous thrombosis and pulmonary embolism within 6 months;
- •Persons with a history of abuse of psychotropic substances and who cannot be cured or have mental disorders;
- •Pregnant and lactating women;
- •Participated in other clinical trials of anti-tumor drugs within 4 weeks;
- •The researcher considered that there were other conditions that were not suitable for inclusion.
研究组 & 干预措施
Anlotinib combined with concurrent chemoradiotherapy
Experimental
Radiotherapy: 1.8-2.0Gy, qd, 54-66Gy, 5 days a week Chemotherapy: squamous cell cancer: paclitaxel + platinum;Adenocarcinoma: pemetrexed + platinum;A cycle of 3W was used, and the appropriate chemotherapy dose was selected by the researcher according to the patient's situation without any restriction on the chemotherapy dose.Pre-induction chemotherapy is allowed.
Anlotinib: QD, take 2 weeks and stop for 1 week (radiotherapy 1, 2, 4, 5 weeks)
干预措施: Anlotinib hydrochloride capsule Combined With Concurrent Chemoradiotherapy (Drug)
结局指标
主要结局
Progress free survival (PFS) for phase Ⅱ
时间窗: up to 30 months
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Maximum Tolerance Dose (MTD) for phaseⅠ
时间窗: From enrollment to completion of study. Estimated about 18months
Maximum Tolerance Dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DLT reported.Dose Limiting Toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 5.0 criteria
次要结局
- Overall Survival (OS)(From randomization until death (up to 30 months))
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to30 months))
研究者
Jinming Yu
Director of the hospital
Shandong Cancer Hospital and Institute
研究点 (1)
Loading locations...
相似试验
撤回
2 期
Evaluating Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung CancerLocally Advanced Non-small Cell Lung CancerEfficacy and SafetyNCT05481775Sun Yat-sen University
Unknown
2 期
Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Combined With Pd-1 AntibodyAdvanced Solid TumorNCT03975036Henan Cancer Hospital100
招募中
2 期
A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of PPGLPheochromocytomaParagangliomaNCT05883085Peking Union Medical College Hospital10
招募中
2 期
Study of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous NSCLC: the Save StudyNon-Squamous Non Small Cell Lung CancerNCT03646968Yongchang Zhang43
尚未招募
2 期
Anlotinib Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical CancerTo Evaluate the Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical CancerNCT05772377The First Affiliated Hospital with Nanjing Medical University36