Locally Advanced Oral Squamous Cell CarcinomaNCT07457099
Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
An observational study of Locally Advanced Oral Squamous Cell Carcinoma and Locally Advanced Oropharyngeal Squamous Cell Carcinoma, run by Zhujiang Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Oral Squamous Cell Carcinoma, Locally Advanced Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Observation, Postoperative Radiotherapy and PD-1 Inhibitor Maintenance Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-80 years) with histologically confirmed, treatment-naïve, locally advanced oral or oropharyngeal squamous cell carcinoma who were surgically resectable and had ECOG performance status 0-1. All participants received two cycles of neoadjuvant immunochemotherapy (tislelizumab plus paclitaxel and platinum) followed by R0 radical surgery and were managed postoperatively with radiotherapy, PD-1 inhibitor maintenance, or observation. Patients with prior head and neck radiotherapy, active autoimmune disease, uncontrolled severe comorbidities, pregnancy/lactation, or incomplete data were excluded.
Who may be able to join
- Age 18-80 years, any gender.
- Expected survival ≥ 6 months.
- Adequate major organ function; ECOG performance status 0-1.
- 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.
- No evidence of distant metastasis based on auxiliary examinations.
- No prior antitumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapies.
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- 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.
Who cannot join
- 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.
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- History of substance abuse, alcoholism, or drug abuse.
- Pregnant or breastfeeding women.
- Participation in other interventional clinical trials simultaneously.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou, Guangzhou, Guangdong 510282
Guangzhou
Xiaozhi LV, 02062782092, lxzsurgeon@126.com
lxzsurgeon@126.com
About this study
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
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
Read the detailed description
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.
- Conditions
- Locally Advanced Oral Squamous Cell Carcinoma, Locally Advanced Oropharyngeal Squamous Cell Carcinoma
- Being tested
- Observation, Postoperative Radiotherapy, PD-1 Inhibitor Maintenance Therapy
- Keywords
- Neoadjuvant immunochemotherapy, oral cancer, oropharyngeal cancer, PD-1 inhibitor, postoperative radiotherapy, event-free survival, pathological response, real-world study
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Also called No postoperative adjuvant therapy, Active surveillance, Observation only
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 RadiotherapyRadiation
Also called Adjuvant radiotherapy, Postoperative radiation therapy (PORT), Radiation therapy after surgery
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 TherapyDrug
Also called Programmed cell death protein 1 inhibitor, Immune checkpoint inhibitor maintenance, PD-1 antibody maintenance
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 group | Role | What they receive |
|---|---|---|
| No Adjuvant Therapy Group | Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery, with no postoperative adjuvant treatment and routine follow-up only. Receives: Other: Observation | |
| Postoperative Radiotherapy Group | Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery and postoperative radiotherapy according to multidisciplinary team decision. Receives: Radiation: Postoperative Radiotherapy | |
| Postoperative Immunotherapy Maintenance Group | Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery and postoperative PD-1 inhibitor maintenance therapy. Receives: Drug: PD-1 Inhibitor Maintenance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Event-Free Survival (EFS)
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.
Measured: 1-Year
Pathological Complete Response (pCR) Rate
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.
Measured: At the time of surgery
Secondary outcomes (8)
1-Year Overall Survival (OS)
Time from the date of surgery to death from any cause or last follow-up.
Measured: 1-Year
Major Pathological Response (MPR) Rate
Major pathological response is defined as ≤10% residual viable tumor cells in the surgical specimen, as determined by histopathological evaluation
Measured: At the time of surgery
Failure Patterns
Distribution of recurrence events categorized as local, regional, or distant.
Measured: 1-Year
Incidence of Grade ≥3 Radiotherapy-Related Toxicities (RTOG/EORTC)
The incidence of grade 3 or higher radiotherapy-related toxicities, assessed according to the Radiation Therapy Oncology Group / European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity criteria.
Toxicity grades range from Grade 0 (no toxicity) to Grade 5 (death related to toxicity), with higher grades indicating more severe toxicity.
Measured: 1-Year
Incidence of Grade ≥3 Immunotherapy-Related Adverse Events (NCI-CTCAE v6.0)
The incidence of grade 3 or higher immunotherapy-related adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0.
Adverse event grades range from Grade 1 (mild) to Grade 5 (death related to adverse events), with higher grades indicating more severe toxicity.
Measured: 1-Year
Swallowing Function
Swallowing function was assessed based on clinically documented swallowing evaluations during follow-up visits, including physician-reported functional assessments.
Functional status was categorized according to institutional clinical practice, with higher functional levels indicating better swallowing ability.
Measured: 1-Year
Nutritional Status Assessed by NRS-2002 Score
Nutritional status was assessed using the Nutritional Risk Screening 2002 (NRS-2002) score.
The NRS-2002 score ranges from 0 to 7, with higher scores indicating greater nutritional risk.
Measured: 1-Year
Quality of Life (Clinically Documented Functional Assessment)
Quality of life was assessed based on clinically documented functional assessments recorded during routine follow-up visits.
Evaluations focused on patient-reported symptoms and functional status related to daily activities.
Measured: 1-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457099
- Sponsor's protocol ID
- 2025-KY-505
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No