Hypopharyngeal cancer
Conditions
Interventions
Single-arm study:Replacement for Relizumab
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.With my consent and having signed the informed consent form, I am willing and capable of adhering to the scheduled visits, research treatments, laboratory tests, and other trial procedures; 2.Patients diagnosed with hypopharyngeal cancer through pathology or cytology; 3.Ages 18 to 75 (inclusive), both men and women are welcome; 4.The clinical staging is classified as stage III-IVB (AJCC 8th edition: T1-4a N1-3 M0); 5.ECOG performance status score of 0-1 in the Eastern Cooperative Oncology Group (ECOG) of the United States; 6.Has not previously received any systemic treatment for hypopharyngeal cancer, including chemotherapy, epidermal growth factor receptor inhibitors such as cetuximab or panitumumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies, and anti-CTLA-4 antibodies; 7.Clearly identifiable measurable lesions that meet the efficacy evaluation criteria for solid tumors (RECIST version 1.1); 8.Based on the laboratory test results obtained during the screening period, the following criteria for adequate organ function must be met: (1) Hematological parameters: no blood transfusions or blood products received within the past 14 days, and no use of G-CSF or other hematopoietic growth factors for correction; white blood cell count (WBC) >= 3.0 × 10^9/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet count (PLT) >= 75 × 10^9/L; hemoglobin (Hgb) >= 9 g/dL; (2) Biochemical parameters: serum total bilirubin = 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 50%. 9.Women of childbearing age participating in the study must undergo a serum pregnancy test within three days prior to the initiation of the study medication, with a negative result. They must also be willing to use a medically approved highly effective contraceptive method (such as an intrauterine device, contraceptive pills, or condoms) during the study period and for three months following the last administration of the study drug. For male participants with female partners of childbearing age, they should either be surgically sterilized or agree to use an effective method of contraception during the study and for three months after the last dose of the study medication.
Exclusion criteria
Exclusion criteria: 1.The presence of other active malignancies in the past or concurrently (excluding malignancies that have been treated with curative intent and have had no recurrence for over five years, as well as in situ cancers that can be cured through adequate treatment); 2.Previously received systemic treatment, surgery, or radiotherapy for hypopharyngeal cancer, including immunotherapy with anti-PD-1 or PD-L1 antibodies, anti-CTLA-4 antibodies, targeted therapies such as anti-EGFR/VEGF agents, and chemotherapy; 3.The use of systemic corticosteroids or other systemic immunosuppressive agents within 2 weeks prior to treatment, or the initiation or anticipated use of systemic immunosuppressive agents during the trial, is prohibited. Inhaled corticosteroids and glucocorticoids at physiological replacement doses are permitted; 4.The patient has a history of autoimmune disease; 5.With my consent and having signed the informed consent form, I am willing and capable of adhering to the scheduled visits, research treatments, laboratory tests, and other trial procedures. 6.Severe uncontrolled systemic diseases, such as serious active infections; 7.It is known that the individual is infected with the Human Immunodeficiency Virus (HIV) or is confirmed to be HIV positive; 8.Individuals with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA > 500 IU/mL) or active HCV carriers with detectable HCV RNA. Note: Non-active hepatitis B surface antigen (HBsAg) carriers and hepatitis B patients who are stable and receiving treatment (HBV DNA < 500 IU/mL) are eligible for inclusion; 9.A history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, or symptomatic interstitial lung disease, or the presence of active pneumonia detected by a chest CT scan within four weeks prior to the initiation of the study drug treatment; 10.Known symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeningeal metastases; 11.Known to be allergic to any investigational drug or excipient; 12.Participants who have taken part in any other drug clinical trials within the four weeks prior to enrollment. 13.Women during breastfeeding and pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who have not undergone local treatment within one year.;1-year progression-free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Quality of Life (Scale);Objective response rate (ORR) after induction therapy;2-year overall survival (OS) rate; | — |
Countries
China
Contacts
Public ContactYulong Zheng
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed