Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Patients With Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy and Radical Surgery: A Single-Center Ambispective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- 1-Year Event-Free Survival (EFS)
研究概览
简要总结
Neoadjuvant immunochemotherapy (NAIC) has demonstrated promising pathological and survival outcomes in patients with resectable locally advanced oral and oropharyngeal squamous cell carcinoma (LA-OSCC/OPSCC). However, the optimal postoperative management strategy following NAIC and radical surgery remains undefined, particularly regarding the necessity of postoperative radiotherapy and the potential role of PD-1 inhibitor maintenance therapy.
This single-center, ambispective cohort study aims to compare event-free survival, pathological response, survival outcomes, failure patterns, treatment-related toxicities, and functional outcomes among three postoperative strategies: postoperative radiotherapy, postoperative PD-1 inhibitor maintenance, and observation alone. The study seeks to provide real-world evidence to support risk-adapted, individualized postoperative decision-making after NAIC
详细描述
Patients with resectable LA-OSCC/OPSCC who received two cycles of neoadjuvant immunochemotherapy consisting of tislelizumab combined with paclitaxel and platinum chemotherapy, followed by R0 radical resection, were included. Based on multidisciplinary clinical decisions, pathological risk stratification, and patient preference, participants were managed postoperatively with one of three strategies:
- Postoperative radiotherapy
- Postoperative PD-1 inhibitor maintenance therapy
- Observation without adjuvant therapy
The study incorporates both retrospective and prospective cohorts using identical eligibility criteria, treatment regimens, follow-up schedules, and outcome assessments to ensure data homogeneity. Survival outcomes, pathological response, treatment-related adverse events, and functional outcomes are systematically evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, any gender.
- •Expected survival ≥ 6 months.
- •Adequate major organ function; ECOG performance status 0-
- •Treatment-naïve patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC), in accordance with the 8th edition of the American Joint Committee on Cancer (AJCC) staging system (2017) and the 2020 Chinese Stomatological Association (CSA) guidelines for pathological diagnosis of oral and oropharyngeal cancers, with clinical stages: cT3N0M0, cT1-3N1M0, cT4aN0-2M0, cT1-4aN3M0, or cT4bN0-3M
- •No evidence of distant metastasis based on auxiliary examinations.
- •No prior antitumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapies.
- •Received 2 cycles of neoadjuvant chemoimmunotherapy (toripalimab + TP regimen) and underwent R0 resection.
- •Women of childbearing potential must agree to use effective contraception during treatment and for 3 months after.
- •Signed informed consent (if the participant lacks capacity, by a legally authorized representative), voluntarily participates in the study, and demonstrates good compliance.
排除标准
- •History of radiotherapy to the head and neck region.
- •Severe bone marrow suppression, hepatic or renal failure, or uncontrolled severe infections, cardiovascular diseases, or other conditions that may preclude tolerance of treatment.
- •Active autoimmune diseases, history of organ transplantation requiring long-term immunosuppressive therapy, or severe immunodeficiency that may result in serious immune-related adverse events.
- •Active infections requiring systemic therapy.
- •Cardiovascular/cerebrovascular events within 6 months prior to study treatment, including myocardial infarction, severe/unstable angina, coronary or peripheral artery bypass surgery, symptomatic heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
- •Bleeding tendency/disorders: clinically significant bleeding or clear bleeding tendency within the past 28 days, including but not limited to gastrointestinal bleeding, epistaxis (excluding mild nosebleeds or blood-streaked sputum), or persistent bleeding/clotting disorders.
- •History of substance abuse, alcoholism, or drug abuse.
- •Pregnant or breastfeeding women.
- •Participation in other interventional clinical trials simultaneously.
研究组 & 干预措施
No Adjuvant Therapy Group
Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery, with no postoperative adjuvant treatment and routine follow-up only.
干预措施: Observation (Other)
Postoperative Radiotherapy Group
Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery and postoperative radiotherapy according to multidisciplinary team decision.
干预措施: Postoperative Radiotherapy (Radiation)
Postoperative Immunotherapy Maintenance Group
Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery and postoperative PD-1 inhibitor maintenance therapy.
干预措施: PD-1 Inhibitor Maintenance Therapy (Drug)
结局指标
主要结局
1-Year Event-Free Survival (EFS)
时间窗: 1-Year
Time from the date of radical surgery to the first occurrence of disease recurrence (local, regional, or distant), disease progression, death from any cause, or last follow-up, whichever occurs first.
Pathological Complete Response (pCR) Rate
时间窗: At the time of surgery
Pathological complete response (pCR) is defined as the absence of residual viable tumor cells in both the primary tumor site and all resected lymph nodes, as assessed by postoperative histopathological examination.
次要结局
- 1-Year Overall Survival (OS)(1-Year)
- Major Pathological Response (MPR) Rate(At the time of surgery)
- Failure Patterns(1-Year)
- Incidence of Grade ≥3 Radiotherapy-Related Toxicities (RTOG/EORTC)(1-Year)
- Incidence of Grade ≥3 Immunotherapy-Related Adverse Events (NCI-CTCAE v6.0)(1-Year)
- Swallowing Function(1-Year)
- Nutritional Status Assessed by NRS-2002 Score(1-Year)
- Quality of Life (Clinically Documented Functional Assessment)(1-Year)