Neoadjuvant EGFR-ADC plus anti-PD-1 therapy for resectable locally advanced hypopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter phase II study examines Becotatug Vedotin (EGFR-ADC) combined with Pucotenlimab (anti-PD-1) as neoadjuvant therapy for resectable locally advanced hypopharyngeal squamous cell carcinoma. Patients receive three cycles every 3 weeks, with radiographic reassessment after two cycles to decide on proceeding to surgery or continuing treatment. Primary endpoints include pathological complete response, with secondary endpoints such as major pathological response, objective response rate, organ preservation, surgery postponement, event-free survival, overall survival, and safety. Participants must meet criteria including age 18 or older, resectable stage III–IV disease without metastasis, measurable disease, good performance status, and adequate organ function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Xudong Wang
• Email: wxd.1133@163.com
• Phone: 86+02223340123-3130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.