Hypopharyngeal Cancer
Conditions
Interventions
Study Arm:Pucotenlimab Combined with Cetuximab and Albumin-Bound Paclitaxel as Neoadjuvant Therapy Sequentially Followed by Radiotherapy for Locally Advanced 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. Histopathologically confirmed locally advanced hypopharyngeal cancer (AJCC 8th Edition Stage III-IVB), ineligible for or refusing surgery. 3. Tumor expresses PD-L1 with Combined Positive Score (CPS) >=1. 4. Unsuitable for or refusing cisplatin, defined by: age >70 years, ECOG PS >2, hearing impairment, renal insufficiency (creatinine clearance Grade 1. 5. At least one measurable lesion per RECIST 1.1 criteria; target lesions must not have received prior local therapy (e.g., radiotherapy). 6. ECOG Performance Status: 0-1. 7. Life expectancy >=3 months. 8. Adequate organ function meeting all criteria below: Hematology (no transfusion within 14 days prior): 1) Hemoglobin (HB) >=90 g/L 2) Absolute Neutrophil Count (ANC) >=1.5 × 10?/L 3) Platelets (PLT) >=75 × 10?/L Biochemistry (no blood product transfusion within 14 days prior): 1) Total bilirubin (BIL) =50 mL/min (Cockcroft-Gault formula) 4) Coagulation: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) =50% by echocardiography. 9. Women of childbearing potential: negative pregnancy test (serum/urine) within 14 days prior to enrollment; willingness to use effective contraception during the study and must be non-lactating. Men: use reliable contraception from treatment initiation until 6 months after last dose. 10. No history of autoimmune diseases. 11. Voluntary participation with signed informed consent, good compliance, and willingness to undergo follow-up.
Exclusion criteria
Exclusion criteria: 1. Receipt of other immunotherapy or anti-EGFR drugs within 4 weeks prior to study treatment initiation. 2. Pregnancy, lactation, or plans for pregnancy during the study period. 3. History of active or prior autoimmune diseases (including inflammatory bowel disease), or syndromes requiring systemic steroids/immunosuppressants (exceptions: vitiligo, asthma/allergic conditions). 4. Active infection requiring systemic antimicrobial/antifungal/antiviral therapy (e.g., tuberculosis). 5. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 6. Uncontrolled severe comorbidities, including: 1) Unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction within 6 months, or severe uncontrolled arrhythmias. 2) Active or uncontrolled severe infections. 7. Hepatic disorders: decompensated cirrhosis, untreated chronic HBV carriers (HBsAg+), or active HCV carriers. Eligible if: inactive HBsAg carrier, treated/stable HBV (HBV DNA <500 IU/mL), or cured HCV. 8. Any other severe comorbidity compromising patient safety or study completion per investigator's judgment.
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;Disease Control Rate ;Time to Disease Progression, TDP;Adverse Event; | — |
Countries
China
Contacts
Public ContactXin Jiang
The First Hospital of Jilin University
Outcome results
None listed