NCT05013697Unknown2 期
A Multicenter Exploratory Study of Paclitaxel+Cisplatin+TQB2450 Injection Combined With or Without Anlotinib in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Progression free survival (PFS， RECIST assessment)
研究概览
简要总结
The regimen of paclitaxel+cisplatin+TQB2450 injection combined or not combined with anlotinib is the first-line treatment of advanced esophageal squamous cell carcinoma. Take PFS as the main evaluation index, the purpose is to evaluate its effectiveness and safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
- •Those who have not received systemic treatment before, or who relapsed after (new) adjuvant therapy/radical surgery more than 6 months ; Note: Including advanced or recurrent Patients who ever received only radiotherapy on non-target lesions. The duration from the end of palliative treatment for local lesions (non-target lesions) to enrollment should > 2 weeks;
- •According to RECIST 1.1, at least one measurable lesion; the measurable lesions should not have received local treatment such as radiotherapy (for the lesions in the area where received local radiotherapy, it can also be regarded as a target lesion if confirmed to progress according to the recist1.1);
- •18 and 75 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy of at least 3 months.
- •the main organ function to meet the following criteria:
- •(1)Blood routine tests met the following requirements:
- •a) haemoglobin(HB)≥90g/L ； b) absolute neutrophil count(NEUT)≥1.5×109/L ； c) platelet count(PLT)≥100×109/L；
- •（2） Biochemical tests met the following requirements： total bilirubin(TBIL)≤ 1.5 times the upper limit of normal (ULN) .≤5 × ULN if with liver involvement； serum creatinine ≤1.5 × the ULN or creatinine clearance≥50mL/min。
- •（3） Coagulation or thyroid function meet the following criteria: International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PT) or activated PTT (APTT) ≤1.5 × (ULN))."
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of study
- •The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study.
排除标准
- •Patients tends to have complete obstruction or patients requiring interventional treatment for obstruction;
- •Patients with a high risk of bleeding or perforation due to the apparent invasion of adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed fistulas;
- •Patients with symptoms of hematemesis, hematochezia and daily bleeding ≥ 2.5 mL, or any bleeding event with Common Terminology Criteria for Adverse Events （CTCAE） level 3 within 3 months before screening;
- •allergic to study drugs 、paclitaxel and cisplatin preparations or excipients;
- •Adjuvant chemotherapy patients who have used paclitaxel or cisplatin, and relapse or metastasize within one year
- •A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- •patients with any severe and / or uncontrolled disease, including:Unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥100) Mmhg) patients; patients with grade ≥ myocardial ischemia or myocardial infarction, arrhythmia (including qt interval ≥ 480ms); according to nyha criteria, iii-iv cardiac dysfunction, or cardiac ultrasonography prompted left ventricular ejection fraction (lvef) <50% of patients;live Severe infection that is sexual or uncontrolled;Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;poor diabetes control (fasting blood glucose (fbg)>10mmol/l);Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g
- •long-term unhealed wounds or fractures;
- •Patients with active hemorrhage within 2 months of primary lesions; pulmonary hemorrhage with NCI CTCAE grade >1, 4 weeks before of enrollment; other sites of bleeding NCI CTCAE grade >2, 4 weeks before of enrollment; patients with bleeding tendency (such as active gastrointestinal ulcers) or patients undergoing thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
- •Have undergone major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks prior to the first dose study or Major surgery is required during the study period.
- •A history of gastrointestinal perforation and/or fistula occurred within 6 months prior to treatment; or an overactive/venous thrombosis event such as a cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and lung Embolism；
- •Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist;
- •Clinically significant ascites, including any ascites that can be found on a physical examination, ascites that has been treated or currently in need of treatment, and only those with a small amount of ascites but no symptoms can be selected;
- •A moderate amount of fluid in both sides of the chest, or a large amount of fluid in one side of the chest, or has caused respiratory dysfunction Patient to be drained;
- •known to have active tuberculosis;
- •suffering from interstitial lung disease requiring steroid therapy;
- •Uncontrolled metabolic disorders or other non-malignant tumors or systemic diseases or cancer secondary reactions that can lead to higher medical risks and/or survival Evaluation of uncertainty;
- •Significantly malnourished patients;
- •those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder;
- •A history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- •History of other primary malignancies, but the following : 1) complete remission of malignant tumors for at least 2 years prior to enrollment and no additional treatment during the study; 2) non-melanoma skin cancer or malignant freckle-like sputum with adequate treatment and no evidence of disease recurrence; 3) adequately treated and In situ carcinoma without evidence of disease recurrence;
- •Female patients who are pregnant or breastfeeding;
- •According to the judgment of the investigator, there is a concomitant disease that seriously endangers the safety of the patient or affects the completion of the study.
研究组 & 干预措施
Experimental group 1
Experimental
Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib (4-6 cycles).
Maintenance treatment: TQB2450 injection+Anlotinib.
干预措施: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib (Drug)
Experimental group 2
Experimental
Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection (4-6 cycles). Maintenance treatment: TQB2450 injection.
干预措施: Paclitaxel + Cisplatin + TQB2450 injection (Drug)
结局指标
主要结局
Progression free survival (PFS， RECIST assessment)
时间窗: each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）
次要结局
- Progression-free survival (iPFS)(each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）)
- Objective response rate (ORR)(each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）)
- Disease control rate (DCR）(each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）)
- Duration of response (DOR)(each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）)
- Incidence of Treatment-related adverse Events(Through study completion, an average of 3 weeks)
研究者
研究点 (5)
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