New study tests best Follow-Up after surgery for oral cancer
NCT ID NCT07457099
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at people with advanced mouth or throat cancer who had chemotherapy and immunotherapy before surgery. After surgery, they will either get radiation, immunotherapy maintenance, or just be watched. The goal is to see which approach helps them live longer without the cancer coming back. About 85 people will take part at one hospital.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1 inhibitor (immunotherapy) and radiotherapy
- What this could lead to
- If successful, this could help doctors choose the best follow-up treatment after surgery for advanced mouth and throat cancers, potentially improving survival and reducing side effects.
- What could go wrong
- This is a small, early-stage study at one hospital, so results may not apply to everyone. The best approach may still be unclear, and both radiotherapy and immunotherapy have risks like severe side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou, Guangzhou, Guangdong 510282
Guangzhou, China
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Other studies related to the condition(s) this trial covers.
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