Can immunotherapy shrink Betel-Nut oral tumors before surgery?
NCT ID NCT07733466
First seen Jul 29, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This trial tests whether giving two immunotherapy drugs—pembrolizumab and cetuximab—before surgery can shrink advanced oral cancers linked to betel-nut chewing. The study enrolls 20 people in the Northern Mariana Islands who have not yet received treatment. Researchers will measure tumor response using CT scans to see if the combination leads to partial or complete shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab and cetuximab
- What this could lead to
- If successful, this approach could shrink tumors before surgery, potentially improving outcomes for people with betel-nut-related oral cancer.
- What could go wrong
- This is a small, early-phase trial with only 20 participants. The combination may cause immune-related side effects, and results may not apply to broader populations.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2031
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 years and older
- 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: * Documented history of betel-nut chewing * confirmed oral cavity squamous cell carcinoma * measurable disease via RECIST 1.1 * Clinical stage III/IV per AJCC 8th edition * treatment-naive * ECOG 0-3 Exclusion Criteria: * Distant metastatic disease * prior treatment for current cancer * active immune disease or other condition requiring immunosuppression or chronic corticosteroid use * active pneumonitis * known hypersensitivity to pembrolizumab or cetuximab * pregnant or breast-feeding * women of childbearing potential without willingness to use contraception during the trial
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Betel-nut-associated oral carcinoma are added.
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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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Northern Marianas Oncology Center | Commonwealth Healthcare Corporation
Saipan, 96950, Northern Mariana Islands