Can immunotherapy before surgery stop early oral cancer from returning?
NCT ID NCT07827872
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2032
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.
- Ages
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18 to 75 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. 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.
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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Sun Yat-sen Memorial Hospital
Guangzhou, Gyangdong, China
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