Can a triple drug combo before surgery stop oral cancer from returning?
NCT ID NCT06258811
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether giving tislelizumab, albumin paclitaxel, and cisplatin before surgery, followed by standard treatment, works better than standard treatment alone for people with locally advanced oral squamous cell carcinoma. The trial enrolls 134 participants with resectable stage III or IVA oral cancer. The goal is to see if this approach improves 2-year event-free and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of tislelizumab, albumin-bound paclitaxel, and cisplatin
- What this could lead to
- If it works, this could point toward a new standard of care that uses immunotherapy plus chemotherapy before surgery to improve cure rates for locally advanced oral cancer.
- What could go wrong
- This is a phase 3 trial, so it is still experimental. The combination may not improve survival over standard therapy, and it can cause serious immune-related side effects or chemotherapy toxicity.
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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 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Dec 2029
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. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1 2. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region) 3. Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC 2018) 4. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) 5. Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3 6. Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) \<2.5 times the upper limit of normal and bilirubin \<1.5 times the upper limit of normal 7. Renal function: Serum creatinine \<1.5 times the upper limit of normal 8. Coagulation function: INR、PT、APTT\<1.5 times the upper limit of normal 9. Signed the informed consent form Exclusion Criteria: 1. Unresolved grade 2 \[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\] or higher toxic reactions caused by previous anticancer treatments 2. Known allergic reaction (grade 3-4) to any ingredients or excipients of the therapy 3. Known history of malignancy, unless been cured and no recurrence for 5 years 4. Known history of radiation to head and neck 5. Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection) 6. Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\] 7. Patients receiving immunology-based treatment for any reason 8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy 9. Pregnant or lactating women 10. Known active hepatitis B or C. Active hepatitis B is defined as a known HBsA positive with HBV DNA≥500 IU/mL. Active hepatitis C is defined as a known hepatitis C antibody positive and a known amount of hepatitis C virus HCV RNA results greater than the lower limit of detection. The presence of other serious liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH) 11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation 12. Participation in other clinical trials within 30 days before enrollment 13. Other situations that the investigator considers unsuitable with respect to participating in the trial
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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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Huashan Hospital, Fudan University
RECRUITINGShanghai, 200040, China
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Other studies related to the condition(s) this trial covers.
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- HIV and oral cancer: what blocks access to care?