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Observational
Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
Condition(s) studied
Locally Advanced Oral Squamous Cell CarcinomaLocally Advanced Oropharyngeal Squamous Cell Carcinoma
Investigational drug(s) / intervention(s)
ObservationPostoperative RadiotherapyPD-1 Inhibitor Maintenance Therapy
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.
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.
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.
Study 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
Eligibility
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.
Primary outcome measure(s)
- 1-Year Event-Free Survival (EFS) — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou, Guangzhou, Guangdong 510282 |
Guangzhou |
China |
|
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