A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Major pathological response（MPR）
研究概览
简要总结
This study aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.
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
- •Patients voluntarily joined the study, signed the informed consent, and had good compliance;
- •Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1;
- •Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers
- •Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.
排除标准
- •Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy;
- •Patients who require systemic treatment with corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses >10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted;
- •A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection);
- •Abnormal function of major organs
- •Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
研究组 & 干预措施
Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy
Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle.
Adjuvant therapy was started within 6 weeks after surgery：Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab).
Non-MPR patients receive standard adjuvant therapy
干预措施: Penpulimab injection (Drug)
Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy
Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle.
Adjuvant therapy was started within 6 weeks after surgery：Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab).
Non-MPR patients receive standard adjuvant therapy
干预措施: cisplatin (Drug)
Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy
Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle.
Adjuvant therapy was started within 6 weeks after surgery：Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab).
Non-MPR patients receive standard adjuvant therapy
干预措施: albumin-paclitaxel (Drug)
结局指标
主要结局
Major pathological response（MPR）
时间窗: One year
Major pathologic response is based on the pathological examination on the post-operative specimens.
次要结局
- Overall Response Rate (ORR)(Baseline up to 3 years.)
- Local recurrence-free survival at 2years(LRFS at 2 years)(Baseline up to 2 years.)
- Disease-free survival at 2 years(DFS at 2 years)(Baseline up to 2 years.)
- Adverse event rate(Baseline up to 3 years.)
- distant metastasis-free survival at 2 years(DMFS at 2 years)(Baseline up to 2 years.)
- Disease-control Rate（DCR）(Baseline up to 3 years.)
- pathologic complete response(pCR)(One year)
- OS at 2 years(Baseline up to 2 years.)