Neoadjuvant Treatment of Locally Advanced Hypopharyngeal Cancer With Adebrelimab Combined With TP Chemotherapy Regimen

Not Applicable

Not yet recruiting

• Conditions: Locally Advanced Hypopharyngeal Cancer
• Interventions: Drug: Adebrelimab+Albumin paclitaxel +Cisplatin

• Registration Number: NCT07137039
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

To evaluate the efficacy and safety of adebrelimab combined with TP chemotherapy regimen as neoadjuvant therapy for locally advanced hypopharyngeal cancer

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study Start: 2025-08-20
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Primary Completion: 2027-08-20
• Study Completion: 2028-08-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• 1. Age: 18 to 70 years old, gender not limited;
• 2.ECOG PS score: 0-1 point;
• 3. Patients who are capable of surgical resection and willing to undergo it;
• 4. Hypopharyngeal cancer diagnosed by histology/cytology and imaging, with a clinical stage of T1-2, N1-3 or T3-4, any N;
• 5. At least one measurable lesion (in accordance with RECIST 1.1 standard);
• 6. The expected survival period is at least 12 weeks;
• 7. Other major organs (liver, kidneys, blood system, etc.) function well: Hemoglobin ≥90g/L (no blood transfusion, no use of hematopoietic factors and no drug correction within 2 weeks before the first administration); Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Total bilirubin ≤1.5 times the upper limit of the normal value; Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase ≤2.5 times the upper limit of the normal value; Serum creatinine ≤1.5 times the upper limit of the normal value, and endogenous creatinine clearance rate ≥60ml/min; For patients who have not received anticoagulant therapy, the international normalized ratio of prothrombin time (INR) is ≤1.5, and the activated partial thromboplastin time (APTT) is ≤1.5 times the upper limit of the normal value.
• 8. Female subjects with fertility must undergo a pregnancy test (serum or urine) within 72 hours before the start of the study medication, and the result must be negative. They must also be willing to use a medically approved efficient contraceptive measure (such as an intrauterine device, contraceptive pill or condom) during the study period and within 90 days after the last administration of the study drug. For male subjects whose partners are women of childbearing age, they must agree to use effective contraception or have undergone surgical sterilization during the study period and within 90 days after the last administration of the study.
• 9. There is no history of allergy to related drug components.
• 10. The subjects voluntarily joined this clinical study and signed the informed consent form.

Exclusion Criteria

• 1. Have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine anti-tumor treatment (except for the treatment of malignant tumors that have been completely cured in the past and have no recurrence or metastasis for ≥5 years);
• 2. Have undergone surgical operations targeting the primary tumor or lymph nodes in the past;
• 3. Patients who have suffered from any malignant tumors in the past five years (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
• 4. Patients with distant metastases;
• 5. Suffering from any active autoimmune disease or a history of autoimmune diseases (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis) Patients with childhood asthma that has been completely relieved and do not require any intervention or systemic treatment in adulthood (such as vitiligo, psoriasis or alopecia) can be included. However, patients who need medical intervention with bronchodilators cannot be included.
• 6. Subjects who have received systemic treatment with corticosteroids (prednisone or other equivalent hormones >10 mg/ day) or other immunosuppressants within 2 weeks prior to the first administration. In the absence of active autoimmune diseases, inhalation or topical use of corticosteroids, as well as adrenal hormone replacement therapy with a dose of ≤10 mg/ day at the therapeutic dose of prednisone, is permitted.
• 7. Those who have experienced hyperactive or venous thrombosis events within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
• 8. Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., have occurred, or are currently receiving thrombolytic or anticoagulant therapy;
• 9. Those with hypertension who have not achieved good control through antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Or grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥450ms in men and ≥470ms in women); According to the NYHA standard, patients with grade Ⅲ to Ⅳ cardiac failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography;
• 10. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein content ≥1g, or severe liver and kidney dysfunction;
• 11. Allergic to the test drug;
• 12. Known human immunodeficiency virus (HIV) infection;
• 13. Pregnant or lactating women; Subjects with fertility who are unwilling or unable to take effective contraceptive measures;
• 14. Those who suffer from neurological or mental disorders and are unable to cooperate;
• 15. Other circumstances that the researchers consider unsuitable for inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Adebrelimab+Albumin paclitaxel +Cisplatin	Adebrelimab combined with albumin, paclitaxel and cisplatin

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR)	Six months	Pathological examination of the resected tissue samples did not reveal any residual tumor cells.

Secondary Outcome Measures

Name	Time	Method
Major pathological response (MPR)	six months	Major pathological response (MPR) is defined as the presence of active tumor tissue in surgical specimens ≤10% at the time of tumor resection.
Surgical R0 resection rate	Six months	The proportion of the resection margin without residual cancer cells
Laryngeal function retention rate	six months	It refers to the proportion of subjects whose laryngeal functions (including vocalization, breathing and swallowing functions) are successfully preserved during the treatment process through methods such as surgery, radiotherapy, chemotherapy or comprehensive treatment.
The intensity of the surgery has decreased	six months	The researchers determined whether the surgical intensity had decreased based on the subjects' conditions.
Objective response rate (ORR)	one year	It refers to the proportion of all subjects whose best overall response (BOR) was rated as complete response (CR) or partial response (PR) according to the RECIST 1.1 standard.
Disease Control rate (DCR)	One year	It refers to the proportion of all subjects whose overall response rate (BOR) was rated as complete response (CR), partial response (PR), and stable disease (SD) according to the RECIST 1.1 standard.
Recurrence-free survival time (RFS)	Two years	It refers to the period from the date of successful surgery to recurrence or death.
Overall survival (OS)	Two years	Defined as the period from the date of the first administration to the death of the subject for various reasons.
Adverse event(AE)	Two years	The incidence and severity of adverse events (AE) evaluated according to CTCAE 5.0

Trial Locations

Locations (1)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China