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NCT07457099

Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma

Sponsor: Zhujiang Hospital

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2028-06-30

Last Updated

2026-03-09

Healthy Volunteers

Conditions

Locally Advanced Oral Squamous Cell Carcinoma Locally Advanced Oropharyngeal Squamous Cell Carcinoma

Interventions

OTHER

Observation

Participants received neoadjuvant immunochemotherapy followed by R0 radical surgical resection. No postoperative adjuvant therapy was administered. Patients were managed with routine clinical follow-up, including scheduled physical examinations, imaging assessments, and functional evaluations according to institutional practice.

RADIATION

Postoperative Radiotherapy

Participants received neoadjuvant immunochemotherapy followed by R0 radical surgical resection and postoperative radiotherapy. Radiotherapy was delivered to the primary tumor bed and regional lymphatic drainage areas according to multidisciplinary team recommendations and institutional guidelines.

DRUG

PD-1 Inhibitor Maintenance Therapy

Participants received neoadjuvant immunochemotherapy followed by R0 radical surgical resection and postoperative immunotherapy maintenance with a PD-1 inhibitor. Immunotherapy was administered at standard dosing intervals according to institutional protocols until disease progression, unacceptable toxicity, or completion of the planned treatment course.

Inclusion Criteria: 1. Age 18-80 years, any gender. 2. Expected survival ≥ 6 months. 3. Adequate major organ function; ECOG performance status 0-1. 4. 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 cT4bN0-3M0. 5. No evidence of distant metastasis based on auxiliary examinations. 6. No prior antitumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapies. 7. Received 2 cycles of neoadjuvant chemoimmunotherapy (toripalimab + TP regimen) and underwent R0 resection. 8. Women of childbearing potential must agree to use effective contraception during treatment and for 3 months after. 9. Signed informed consent (if the participant lacks capacity, by a legally authorized representative), voluntarily participates in the study, and demonstrates good compliance. Exclusion Criteria: 1. History of radiotherapy to the head and neck region. 2. Severe bone marrow suppression, hepatic or renal failure, or uncontrolled severe infections, cardiovascular diseases, or other conditions that may preclude tolerance of treatment. 3. Active autoimmune diseases, history of organ transplantation requiring long-term immunosuppressive therapy, or severe immunodeficiency that may result in serious immune-related adverse events. 4. Active infections requiring systemic therapy. 5. 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. 6. 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. 7. History of substance abuse, alcoholism, or drug abuse. 8. Pregnant or breastfeeding women. 9. Participation in other interventional clinical trials simultaneously.

Locations (1)

Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou, Guangzhou, Guangdong 510282

Guangzhou, China