NCT06151743 Neoadjuvant PD-1 Inhibitor Combined With Cetuximab and Platinum in Resectable Locally Advanced Hypopharyngeal Carcinoma
| NCT ID | NCT06151743 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Locally Advanced Hypopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2024-01-18 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this clinical trial is to evaluate the efficacy and safety of immunotherapy combined with cetuximab and platinum neoadjuvant therapy in patients with resectable locally advanced hypopharyngeal cancer. Participants will receive three cycles of TPC neoadjuvant therapy (toripalimab+ cetuximab + platinum), radical surgery (laryngeal preservation surgery if possible), and sequential (chemo)radiotherapy treatment after surgery. This trial aims to answer the following questions: 1. pCR rate 2. MPR rate, ORR, LPR/DFS/OS rare at 1 and 2 years 3. Safety and quality of life
Eligibility Criteria
Inclusion Criteria: * Pathologically confirmed as hypopharyngeal squamous cell carcinoma; * Age between 18-75 years; * Patients with resectable locally advanced hypopharyngeal cancer with T3-4aN0-3bM0 (AJCC 8th) require total laryngectomy; * Have at least one evaluable target lesion according to RECIST 1.1 criteria. * No previous treatment for hypopharyngeal carcinoma; * Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1; * Estimated survival ≥ 6 months; * Normal organ function; * HBV DNA \< 500 IU/mL (or 2500 copies/mL) and HCV RNA negative; * Signed informed consent; * Patients who are compliant, willing, and able to follow visiting schedules, treatment plans, laboratory tests, and other research procedures. * Male and no pregnant female; able to use the contraceptive method during treatment. Exclusion Criteria: * Have a history of other cancers in the past five years, except for the following cancers that are cured in the past five years: basal cell carcinoma and squamous cell carcinoma of the skin, early prostate cancer, papillary thyroid cancer, breast ductal carcinoma in situ and cervix carcinoma in situ; * The target lesion has been treated with radiation therapy or surgery, except for biopsy to confirm the diagnosis of hypopharyngeal carcinoma; * Previous chemotherapy, immunotherapy, or bio-targeted therapy for the primary tumor; * Patients who have participated in other clinical trials within four weeks before the trial; * Any of the following diseases within six months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. * Those with hypertension who cannot be reduced to normal range by antihypertensive drugs (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg). * Patients with grade I or above coronary heart disease, arrhythmia (including QTc interval prolongation \> 450 ms for men and \> 470 ms for women), and cardiac insufficiency. * Patients with positive urine protein (urine protein test 2 + or above, or 24-hour urine protein quantification \>1.0g). * Patients with severe allergic history or allergic constitution; an active autoimmune disease that may worsen when receiving immunostimulants. Patients with type I diabetes, vitiligo, psoriasis, or diseases of hypothyroidism or hyperthyroidism that do not require immunosuppressive therapy are eligible to participate in the study. * Subjects requiring systemic therapy with corticosteroids (\> 10 mg prednisone or equivalent) or other immunosuppressants within two weeks before the first use of the study drug. * Previously diagnosed immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) - related disease. hepatitis B virus (HBV) surface antigen positive and HBV-DNA ≥ 500 IU/mL (or 2500 copies/mL), or HCV RNA positive. History of active or previous tuberculosis (TB). * Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders. * Vaccination within four weeks before enrollment, except for inactivated vaccine. * Pregnant or lactating women, those who are in the reproductive period and do not use effective contraception; * Those whom the investigator deems unsuitable to participate in this trial, such as severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or psychiatric illness (including recent or active suicidal ideation or behavior) or abnormal laboratory tests.
Contact & Investigator
Lei Tao
PRINCIPAL INVESTIGATOR
Eye & ENT Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06151743 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced Hypopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06151743 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06151743 currently recruiting?
Yes, NCT06151743 is actively recruiting participants. Contact the research team at doctortaolei@163.com for enrollment information.
Where is the NCT06151743 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06151743 clinical trial?
NCT06151743 is sponsored by Eye & ENT Hospital of Fudan University. The principal investigator is Lei Tao at Eye & ENT Hospital of Fudan University. The trial plans to enroll 32 participants.