Toripalimab Plus TPF Inductive Chemotherapy and Definitive Radiotherapy for Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Efficacy and Safety: a Phase II Prospective Cohort Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Complete remission rate
研究概览
简要总结
TPF is the standard regime of inductive chemotherapy for squamous carcinoma of head and neck. If the primary tumor shrinks obviously (complete remission or >75% partial remission )after inductive chemotherapy, CCRT is suggested as the definitive therapy, for the tumor is sensitive to chemotherapy. If the primary tumor shrinks a little or progresses after inductive chemotherapy, operation is suggested as the definitive therapy to get a longer survival.
详细描述
Inductive chemotherapy plus CCRT or operation is an option of organ preservation for patients of hypopharyngeal carcinoma. Many clinical studies have demonstrated that inductive chemotherapy plus CCRT achieved the same prognosis as total laryngectomy, and minimized the damage of normal tissue. TPF is the standard regime of inductive chemotherapy for squamous carcinoma of head and neck. If the primary tumor shrinks obviously (complete remission or >75% partial remission )after inductive chemotherapy, CCRT is suggested as the definitive therapy, for the tumor is sensitive to chemotherapy. If the primary tumor shrinks a little or progresses after inductive chemotherapy, operation is suggested as the definitive therapy to get a longer survival. This is a prospective, phase II, cohort study. We designate TPF plus Toripalimab as the inductive regime, expecting a higher complete remission rate and longer PFS and OS. And we replace the CCRT with radiation plus Toripalimab to decrease the adverse events of CCRT.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18y ≤age≤65y;
- •Histology：squamous cell carcinoma, located in hypopharynx;
- •clinical stage: cT1N1-3M0、cT2-3N0-3M0，organ-preservation-intent regime is made after multidisciplinary treatment(MDT) discussion. Efficacy evaluation will be made according to RECIST 1.1 after inductive chemotherapy, and the following treatment will be chosen according to the results of efficacy evaluation.
- •never received any previous treatment, including radiotherapy, chemotherapy, or immune therapy, et al.
- •at least one measurable lesion (RECIST 1.1 criteria).
- •expected survival ≥6 months.
- •no contraindications of radiotherapy, chemotherapy and immune therapy.
- •functions of main organs A. WBC≥3.0x109 /L，ANC≥1.5x109/L B. HB≥90g/L C. PLT≥100x109 /L D. serum albumin≥2.8g/dL E. TBil ≤1.5xULN，ALT、AST≤3.0xULN F. serum creatinine ≤1.5xULN or creatinine clearance rate>60mL/min（Cockcroft-Gault） G. APTT and INR ≤1.5xULN
- •contraception
- •voluntary and compliance.
排除标准
- •other histology cancers located in hypopharynx.
- •synchronous or metachronous cancers located in other sites.
- •allergy to monoclonal antibody.
- •uncontrollable heart disease or symptoms.
- •uncontrollable infections.
- •fever of unknown origin>38.5℃ during screening or before administration.
- •active autoimmune disease.
- •history of immunodeficiency disorders, including HIV.
- •active HBV or HCV.
- •history of interstitial lung disease.
- •active tuberculosis.
- •received any drugs listed below: A. received any study drug 4 weeks before first dose of Toripalimab. B. received any anti-cancer drug 4 weeks before first dose of Toripalimab. C. received any glucocorticoids （>10mg prednison per day） 2 weeks before first dose of Toripalimab.
- •D. received any cancer vaccine 4 weeks before first dose of Toripalimab. E. received any operation or trauma 4 weeks before first dose of Toripalimab. F. recruited in other study.
- •uncontrollable hypertension.
- •uncontrollable type 2 diabetes；
- •hemorrhagic tendency.
- •drug or alcoholic abuse.
- •woman during pregnancy or lactation period.
研究组 & 干预措施
TPF inductive chemotherapy plus Toripalimab and radiotherapy plus Toripalimab
TPF inductive chemotherapy plus Toripalimab for 3 cycles, and radiotherapy plus Toripalimab if the inductive treatment efficacy is CR or >75%PR. If not, operation is suggested.
干预措施: Toripalimab (Drug)
结局指标
主要结局
Complete remission rate
时间窗: 3 months after treatment
Complete remission rate 3 months after treatment
次要结局
- OS(5 year)
- DCR(5 year)
- PFS(5 year)
- ORR(3 months after treatment)
研究者
Sun Yan
Principal Investigator, Chief of Head and Heck Group of Radiotherapy Department, Peking University Cancer Hospital, Peking University
Peking University