Promising drug cocktail aims to save voice boxes in throat cancer patients
NCT ID NCT07665190
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This phase II trial tests two drugs—becotatug vedotin and pucotenlimab—given before surgery to people with advanced hypopharyngeal cancer. The goal is to shrink tumors enough to improve surgical outcomes and possibly preserve the voice box. About 52 participants will receive three cycles of the combination, and researchers will measure how many have no cancer cells left in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- becotatug vedotin and pucotenlimab (drug combination)
- What this could lead to
- If successful, this combination could shrink tumors before surgery, potentially allowing more patients to avoid removal of the voice box and improve long-term survival.
- What could go wrong
- This is an early phase II trial with only 52 participants, so results may not apply to all patients. The drugs can cause side effects like infusion reactions or immune-related inflammation.
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 52 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
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: 1. Aged ≥ 18, male or female; 2. Histopathologically confirmed Hypopharyngeal Squamous Cell Carcinoma; 3. Surgically resectable, Clinical Stage III or IV and no distant metastasis (AJCC 8th edition); 3\. Measurable primary lesions per RECIST v1.1; 5.Treatment-naive (no prior anti-tumor therapy for current disease); 6.ECOG performance status 0-1; 7.Estimated life expectancy \>= 3 months; 8.Have adequate organ function as defined by laboratory parameters; 9.No contraindications to chemotherapy, targeted therapy, or immunotherapy; 10.No history of immune-related diseases; 11.No uncontrolled pneumonia or pulmonary infection; 12.Female participants of childbearing potential must agree to use effective contraception during the trial; A serum or urine pregnancy test must be negative within 72 hours prior to the start of chemotherapy; 13.The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures. Exclusion Criteria: 1. Patients with distant metastasis; 2. Patients with uncontrolled severe medical conditions; 3. Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies; 4. Uncontrolled cardiac clinical symptoms or diseases; 5. Occurrence of severe infection (CTCAE Grade \> 2) within 4 weeks prior to the first dose of the study drug; 6. Unexplained fever \> 38.5°C during the screening period or before the first dose; 7. Active autoimmune disease or a history of autoimmune disease; 8. History of immunodeficiency, or a history of organ transplantation or allogeneic bone marrow transplantation; 9. Patients with untreated chronic hepatitis B, or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or patients with active hepatitis C virus (HCV) must be excluded; 10. History of interstitial lung disease; 11. Patients with active pulmonary tuberculosis infection identified by medical history or CT scan; 12. Patients who have received any of the following treatments: A. Receipt of any investigational drug or anti-cancer therapy within 4 weeks prior to the first dose of the study drug; B. Requirement for systemic treatment with corticosteroids (daily dose \> 10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of the study drug.; C. Prior vaccination with an anti-tumor vaccine or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug; D. Major surgery or significant traumatic injury within 4 weeks prior to the first dose of the study drug; E. Concurrent enrollment in another clinical study; 13. Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires; 14. Subjects with peripheral neuropathy ≥ Grade 2 according to CTCAE V5.0; 15. History of allergy or hypersensitivity to any component of the study treatment; 16. History of a primary malignancy other than head and neck squamous cell carcinoma within the previous 5 years; 17. Requirement for concurrent treatment with other anti-tumor therapies; 18. Patients deemed unsuitable for enrollment by the investigator; 19. Pregnant or breastfeeding women.
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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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Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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