NCT06656091尚未招募3 期
Simmitinib Versus Investigator's Choice of Chemotherapy for Participants With Advanced or Metastatic Oesophageal Squamous Cell Carcinoma : a Randomised, Open-label, Multicentre, Phase 3 Study
Shanghai Runshi Pharmaceutical Technology Co., Ltd0 个研究点目标入组 450 人开始时间: 2024年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 主要终点
- OS
研究概览
简要总结
To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.
详细描述
This is a randomised, open-label, multicentre, phase 3 study. Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy will be randomly assigned to the experimental group or control group in a 1:1 ratio. The experimental group received treatment with Simmitinib, while the control group received investigator's choice of chemotherapy, include docetaxel or irinotecan.
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
- •Have fully understood and voluntarily sign the ICF for this study;
- •Age of 18-75 years (inclusive), male or female；
- •Histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable, local recurrence or with distant metastasis；
- •Second-line patients with disease progression after only first-line standard therapy（Standard treatment: Chemotherapy with platinum, paclitaxel, or fluorouracil combined with immunosuppressive regimen. Progression during maintenance therapy will be allowed.Concurrent chemoradiotherapy with recurrence or metastasis after surgery is considered as first-line treatment. Progression during Concurrent chemoradiotherapy/ adjuvant/neoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）;
- •At least one evaluable lesion according to RECIST 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;
- •Expected survival is more than 3 months；
- •Have recovered from any prior adverse effects of chemotherapy, surgery, radiation, or other antitumor therapy to CTCAE V5.0 criteria ≤ Grade 1 or baseline (except for toxicity such as hair loss that the investigator determines is not a safety risk)；
- •Adequate organ function, defined as:
- •Absolute Neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- •Platelet count (PLT) ≥ 100× 10^9/L;
- •Hemoglobin (Hb) ≥ 90 g/L;
- •Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL/min(According to the Cockcroft-Gault formula);
- •Serum total bilirubin (TBIL) ≤ 1.5 × ULN;
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases);
- •Prothrombin time (PT)、activated partial thromboplastin time (APTT)、international normalized ratio(INR)≤1.5 × ULN(No previous anticoagulant therapy)
- •Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment. Female participants must have a negative serum or urine pregnancy test result within 7 days prior to randomization and must be non-lactating.
排除标准
- •Patients who have previously received any anti-tumor therapy within 4 weeks prior to randomization;
- •Patients who have previously received major surgical treatment、open biopsy、other clinical trial drug treatment or any live attenuated vaccine within 4 weeks prior to randomization, or are expected to received any live attenuated vaccine during the study.
- •Patients who have previous treatment with anti-angiogenic drugs (such as anlotinib, apatinib, Fruquintinib, Surufatinib, Bevacizumab, etc.)
- •LVEF <50%；
- •BMI≤18.5 kg/m^2；
- •Symptomatic central nervous system (CNS) metastases or meningeal metastases
- •Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ；
- •Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months；
- •Urine protein ≥ ++ and 24 h urine protein > 1.0 g at screening period；
- •Presence of any severe and/or uncontrolled disease before starting treatment；
- •Patients with Liver cirrhosis or active hepatitis；
- •Patients with abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before randomization；
- •Patient previously had or currently has a mental disorder or suffers from epilepsy and requires treatment；
- •Patients had prior retinal pigment epithelial detachment or have evidence of ongoing retinal pigment epithelial detachment；
- •Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to randomization;
- •Patients had prior interstitial lung disease,or have evidence of active non-infectious pneumonia treated with corticosteroids；
- •Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders.
研究组 & 干预措施
simmitinib
Experimental
simmitinib 6mg,QD ,3 weeks on 1 week off
干预措施: simmitinib (Drug)
investigator's choice of chemotherapy
Active Comparator
docetaxel injection 75mg/m^2,d1,every 3 weeks；or ilinotecan injection 180mg/m^2,d1,every 2 weeks
干预措施: investigator's choice of chemotherapy,include docetaxel or irinotecan. (Drug)
结局指标
主要结局
OS
时间窗: up to approximately 3 years
次要结局
- ORR(up to approximately 3 years)
- PFS(up to approximately 3 years)
- DCR(up to approximately 3 years)
- DOR(up to approximately 3 years)
- AE(From first dose to 28 days post the last dose)
- FGF19 protein expression, FGF gene amplification status(baseline)
- PK(Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle is 28 days))
研究者
相似试验
招募中
2 期
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT06463834Fujian Cancer Hospital30
尚未招募
2 期
Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter StudyNasopharyngeal CarcinomaNCT05417139Sun Yat-sen University43
Unknown
2 期
Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Operable Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT05174325The First Affiliated Hospital of Soochow University30
进行中（未招募）
不适用
Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLCCarcinoma, Non-Small-Cell LungLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsNCT06376084AstraZeneca532
已完成
2 期
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)Acute Lymphoblastic LeukemiaNCT00130195Japan Adult Leukemia Study Group100