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New study tests best Follow-Up after surgery for oral cancer

NCT ID NCT07457099

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 85 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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

    Guangzhou, China

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