NCT04716751尚未招募2 期
Clinical Study of Neoadjuvant Anti-PD-1 Drug Toripalimab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Shanghai Pulmonary Hospital, Shanghai, China0 个研究点目标入组 15 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Safety: frequency of severe adverse events
研究概览
简要总结
This is a single-arm, open, II phase study to evaluate the safety and efficacy of Toripalimab + carboplatin + paclitaxel in 15 newly diagnosed patients with tracheal malignant tumors.
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
- •Bronchoscopic biopsy confirmed as tracheal malignant tumor by pathological examination
- •PET-CT confirmed no metastasis;
- •ECOG physical status score 0-1;
- •Bronchoscopy, chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy.
- •Age ≥ 18 years;
- •Have one measurable lesions at least;
- •Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
- •Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after chemotherapy or the last administration of triplizumab, whichever is later, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after chemotherapy or the last administration of triplizumab, whichever is the later.
- •Sign informed consent;
排除标准
- •Systemic anticancer therapy for tracheal malignant tumors, including surgery, radiotherapy, chemotherapy, targeted therapy and experimental therapy.
- •Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;
- •Patients with other malignant tumors in the five years before the start of this trial.
- •Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;
- •Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- •The infection was treated with antibiotics within 4 weeks before the start of the trial;
- •A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
- •Had or is suffering from nephrotic syndrome
- •Has been or is suffering from chronic obstructive pneumonia, bronchiectasis, or interstitial lung disease;
- •Allergic to experimental drugs;
- •Complicated with HIV infection or active hepatitis.
- •Vaccination within 4 weeks before the start of this trial;
- •Those who had undergone other major operations or severe injuries within the previous 2 months;
- •Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;
- •Pregnant or lactating women;
- •Those with neurological diseases or mental disorders.
- •Participated in another therapeutic clinical study at the same time;
- •Other researchers did not consider it appropriate to enroll in the group.
研究组 & 干预措施
Toripalimab
Experimental
干预措施: Toripalimab (Drug)
结局指标
主要结局
Safety: frequency of severe adverse events
时间窗: up to 5 months
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Major pathologic response (MPR)
时间窗: up to 4 months
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
次要结局
- Progression-free survival (PFS)(up to 60 months)
- Overall survival (OS)(up to 60 months)
- Duration of remission (DOR)(up to 60 months)
- Disease control rate (DCR)(up to 60 months)
- Health related quality of life (HRQol)(up to 6 months)
研究者
Peng Zhang
Director of thoracic department
Shanghai Pulmonary Hospital, Shanghai, China
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