Phase II Trial of Neoadjuvant Toripalimab in Combination With Chemotherapy Followed by Transoral Robotic Surgery or Risk/Response Stratified Chemoradiotherapy for Locoregional HPV16+ Oropharyngeal Cancer: TARGET HPV Cohort 2
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Deep Response Rate (DRR) with toripalimab + chemotherapy
概览
简要总结
This is a single-center phase 2 study of to test how well the combination of toripalimab with chemotherapy followed by TORS or risk and response stratified de-escalated (chemo)radiotherapy works in patients with in HPV16+ locoregionally advanced oropharyngeal cancer (OPC).
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
- •Subjects must have pathologically confirmed HPV16-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.
- •HPV16 subtype demonstrated based on the following guidelines:
- •p16 IHC positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al72).
- •HPV PCR must demonstrate HPV16 subtype.
- •Following p16 IHC positivity, HPV16 is to be demonstrated using HPV PCR which is anticipated to result prior to cycle 1 day
- •Patients must be at least 18 years of age.
- •Subjects with AJCC (8th edition, 2018) N1 (if solitary lymph node must be \>=3cm), N2-N3 nodal disease or T3-T4 primary tumor (with any N).
- •Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria.
- •No previous radiation or chemotherapy for a head and neck cancer.
- •No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.) No surgical procedures or biopsies will occur after baseline scans are performed and measurable lesions are identified.
排除标准
- •Unequivocal demonstration of distant metastatic disease (M1 disease).
- •Non-HPV16 subtype.
- •Unidentifiable primary site.
- •Intercurrent medical illnesses that impairs the patient's tolerance to therapy or limits survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Patients with clinically stable and/or chronically managed medical illnesses that are not symptomatic and/or are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility).
- •Subject with low risk N1 disease (defined as single lymph node \<3cm)
- •Active, known, or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy, with the exception of low-dose prednisone (\<= 10mg or equivalent). The following are exceptions to these criteria:
- •Patients with vitiligo or alopecia.
- •Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
- •Any chronic skin condition that does not require systemic treatment.
- •Treatment with immunosuppressive or replacement medication:
研究组 & 干预措施
Toripalimab and Chemotherapy Treatment
Participants will receive toripalimab with neoadjuvant chemotherapy. After completion of the study treatment all patients will proceed with risk and response stratified locoregional therapy.
干预措施: Toripalimab (Drug)
Toripalimab and Chemotherapy Treatment
Participants will receive toripalimab with neoadjuvant chemotherapy. After completion of the study treatment all patients will proceed with risk and response stratified locoregional therapy.
干预措施: Carboplatin (Drug)
Toripalimab and Chemotherapy Treatment
Participants will receive toripalimab with neoadjuvant chemotherapy. After completion of the study treatment all patients will proceed with risk and response stratified locoregional therapy.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Deep Response Rate (DRR) with toripalimab + chemotherapy
时间窗: After treatment completion (about 3 months)
The proportion of patients who attain a deep response following neoadjuvant toriaplimab + chemotherapy. DDR is defined as tumor shrinkage by 50% or more.
次要结局
- Locoregional Control(5 years after treatment completion)
- Distant Control(5 years after treatment completion)
- Side effects of toripalimab + chemotherapy(After treatment completion (about 3 months))
- Progression Free Survival(5 years after treatment completion)
- Overall Survival(5 years after treatment completion)
- Treatment adherence(After treatment completion (about 3 months))