A Safety, Feasibility and Efficacy Study of Gemcitabine Plus Docetaxel Plus Toripalimab (GDT) Induction as Part of a Curative Sequential Chemoradiation for Patients With Locoregional EBV Associated Nasopharyngeal Carcinoma (NPC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Induction chemotherapy completion rate
研究概览
简要总结
The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-
- •No M1) per AJCC v 8
- •Prior therapy: None for NPC permitted
- •Life expectancy: 3 months at least
- •Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose.
- •ECOG Performance Status of 0,1, or 2
- •Age: At least 18 years old.
- •CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows:
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- •Platelets ≥ 100,000 cells/mm3;
- •Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
- •Adequate hepatic function within 21 days prior to day 1 of treatment, defined as follows:
- •Total bilirubin ≤ 1.5 x institutional ULN;
- •AST and ALT ≤ 1.5 x institutional ULN;
- •Adequate renal function within 21 days prior to day 1 of treatment, defined as follows:
- •Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min
- •Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential
- •Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
排除标准
- •Prior systemic anticancer treatment for NPC
- •Prior radiation to head and neck region or regions necessitating overlapping fields
- •Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
- •History of allergic reactions to any agents in this study
- •Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
- •Pregnant or breastfeeding
- •Severe, active co-morbidity, defined as follows:
- •Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;
- •Unstable angina and/or uncontrolled congestive heart failure within past 6 months;
- •Myocardial infarction within the last 6 months;
- •Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible.
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment;
- •Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
- •Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
- •≥ grade 2 peripheral sensory neuropathy
研究组 & 干预措施
Gemcitabine, Docetaxel and Capecitabine
Patients will receive three q 21-day cycles of gemcitabine 1000 mg/m2 plus docetaxel 75 mg/m2 plus toripalimab 240 mg, followed by radiation to 70 Gy plus concurrent weekly cisplatin, 40 mg/m2 up to 7 doses, followed by adjuvant capecitabine 650 mg/m2 BID for one year plus toripalimab 240 mg q 21 days for 9 doses.
干预措施: Toripalimab (Drug)
Gemcitabine, Docetaxel and Capecitabine
Patients will receive three q 21-day cycles of gemcitabine 1000 mg/m2 plus docetaxel 75 mg/m2 plus toripalimab 240 mg, followed by radiation to 70 Gy plus concurrent weekly cisplatin, 40 mg/m2 up to 7 doses, followed by adjuvant capecitabine 650 mg/m2 BID for one year plus toripalimab 240 mg q 21 days for 9 doses.
干预措施: Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation (Radiation)
结局指标
主要结局
Induction chemotherapy completion rate
时间窗: 3 years
Induction chemotherapy completion rate, defined as the proportion of patients who complete three cycles of chemoimmunotherapy within 12 weeks of initiation. Completion is defined for induction as receiving all 3 cycles as planned, including protocol specified dose reduction and delays. .
Radiation completion rate
时间窗: 3 years
Radiation completion rate, defined as the proportion of patients who complete specified radiation within 8 weeks of radiation initiation. Radiation completion is defined as completion of planned doses of radiation.
次要结局
- Overall Response (ORD) rate following induction(3 years)
- Complete Response (CR) rate following radiation(3 years)