Hypopharyngeal Cancer
Conditions
Interventions
Study Arm:Cetuximab in Combination with Pucotenlimab and Nab-Paclitaxel for the Treatment of Recurrent or Metastatic Hypopharyngeal Cancer
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years, regardless of gender. 2. Diagnosis: Histologically or cytologically confirmed locally recurrent or metastatic hypopharyngeal carcinoma, deemed unsuitable for local therapy (e.g., surgery or radiotherapy) by the investigator. 3. Biomarker: Tumor expresses PD-L1 with a Combined Positive Score (CPS) >=1. 4. Cisplatin Ineligibility: Ineligible for or refusal of cisplatin, defined by one or more of: Age >70 years, ECOG Performance Status (PS) >2, Hearing impairment, Renal insufficiency (creatinine clearance 1 peripheral neuropathy. 5. Measurable Disease: At least one measurable lesion per RECIST v1.1. Note: Target lesions must be naïve to prior radiotherapy. 6. Performance Status: ECOG PS 0–1. 7. Life Expectancy: >=3 months. 8. Adequate Organ Function: Hematology(without transfusion within 14 days prior to screening): 1)Hemoglobin (Hb) >=90 g/L 2)Absolute Neutrophil Count (ANC) >=1.5 × 10?/L 3)Platelets (PLT) >=75 × 10?/L Biochemistry(without transfusion within 14 days prior to screening): 1) Total bilirubin =1.5 × ULN (=3 × ULN for Gilbert’s syndrome) 2) ALT/AST =2.5 × ULN (=5 × ULN with liver metastases) 3) Serum creatinine =1.5 × ULN or creatinine clearance >=50 mL/min (Cockcroft-Gault) 4) Coagulation: APTT, INR, PT =1.5 × ULN 5) Cardiac: Left ventricular ejection fraction (LVEF) >=50% by Doppler echocardiography. 9. Women of childbearing potential: Negative pregnancy test (serum/urine) within 14 days prior to enrollment; agreement to use reliable contraception during the trial; non-lactating; Men: Use of reliable contraception from treatment initiation until 6 months after the last dose. 10. Voluntarily enrolled, signed informed consent, and committed to follow-up. 11. No history of autoimmune diseases. 12. Ethics: Written informed consent obtained prior to any trial-related procedures.
Exclusion criteria
Exclusion criteria: 1. Received local therapy (e.g., surgery, radiotherapy), immunotherapy, or anti-EGFR drugs within 4 weeks prior to initiation of study treatment. 2. Pregnancy, lactation, or intention to become pregnant during the study period. 3. History or active autoimmune diseases (including inflammatory bowel disease), or syndromes requiring systemic steroids/immunosuppressants. Exceptions: Vitiligo, asthma/allergies. 4. Active infection requiring systemic antimicrobial/antifungal/antiviral therapy (e.g., tuberculosis). 5. History of allogeneic organ or hematopoietic stem cell transplantation. 6. Severe and/or uncontrolled conditions, including: 1) Unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction within 6 months before screening, or severe uncontrolled arrhythmias; 2) Active or uncontrolled severe infections. 7. Patients will be excluded if they have liver diseases including decompensated cirrhosis, untreated chronic hepatitis B virus (HBV) carriers, or active hepatitis C virus (HCV) carriers; however, inactive hepatitis B surface antigen (HBsAg) carriers, HBV patients with antiviral therapy and stable disease control (HBV DNA < 500 IU/mL), or cured HCV patients (achieving sustained virologic response, SVR12) are eligible. 8. Patients will be excluded if they have concomitant illnesses that, in the investigator's judgment, would compromise patient safety or interfere with the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate;1-year progression-free survival rate;Duration of Response ;Disease Control Rate ;Adverse Event; | — |
Countries
China
Contacts
Public ContactXin Jiang
The First Hospital of Jilin University
Outcome results
None listed