Can immunotherapy before surgery stop early oral cancer from returning?

NCT ID NCT07827872

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

This phase 3 trial tests whether adding sintilimab, an immunotherapy drug, to chemotherapy before surgery helps people with early-stage oral squamous cell carcinoma. Participants are adults aged 18 to 75 with cT2N0M0 oral cancer that can be removed by surgery. Half receive sintilimab plus nab-paclitaxel and carboplatin for 2 to 3 cycles before surgery, while the other half go straight to surgery. Researchers compare how many people remain cancer-free after 3 years and how well the tumor responds to treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sintilimab, an immunotherapy drug, combined with the chemotherapy drugs nab-paclitaxel and carboplatin
What this could lead to
If it works, giving immunotherapy plus chemotherapy before surgery could become a new standard approach for early oral cancer, helping more people stay cancer-free after treatment.
What could go wrong
This is a phase 3 trial, so results are not yet known. Adding immunotherapy and chemotherapy before surgery can cause side effects, and it may not improve survival compared with surgery alone. The findings may not apply to all oral cancer patients.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2032

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.

Ages

18 to 75 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. Histologically confirmed primary squamous cell carcinoma of the oral cavity. 2. Clinical stage cT2N0M0 according to the AJCC 8th edition staging system. 3. Age between 18 and 75 years old. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Deemed eligible for radical surgical resection of the primary tumor and regional lymph nodes. 6. Adequate organ function within 14 days prior to randomization: * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelets \>= 100 x 10\^9/L * Hemoglobin \>= 9.0 g/dL * Total bilirubin \<= 1.5 x upper limit of normal (ULN) * AST and ALT \<= 2.5 x ULN * Serum creatinine \<= 1.5 x ULN or creatinine clearance \>= 50 mL/min 7. Voluntary written informed consent provided by the patient or legal representative. Exclusion Criteria: 1. Presence of regional lymph node metastasis or distant metastasis (cN+ or M1). 2. Prior systemic antitumor therapy, radiotherapy, or immunotherapy for head and neck cancer. 3. History of other active malignant neoplasms within the past 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ). 4. Active autoimmune disease or history of severe autoimmune disease requiring systemic corticosteroids or immunosuppressive agents. 5. Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, or uncontrolled heart failure (NYHA Class III/IV). 6. Active infection requiring systemic intravenous antimicrobial treatment. 7. Known history of severe allergy or hypersensitivity to sintilimab, albumin-bound paclitaxel, carboplatin, or their excipients. 8. Pregnant or breastfeeding women, or patients of childbearing potential unwilling to use effective contraception during the study and for 6 months after the last dose. 9. Any underlying medical condition or psychiatric disorder that, in the opinion of the investigator, would jeopardize participant safety or trial compliance.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Mouth Neoplasms oral cavity squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

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

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Gyangdong, China

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