Salivary Gland Cancer
Conditions
Interventions
Observation group:None
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years; 2. Histopathologically confirmed diagnosis of salivary gland cancer; 3. Tumor tissue available in sufficient quantity for in vitro organoid culture; 4. Presence of measurable lesion(s); 5. ECOG performance status: 0–2; 6. Life expectancy > 3 months; 7. Adequate major organ function to tolerate chemotherapy, targeted therapy, or immunotherapy: a. Hematology criteria: WBC >= 4.0×10?/L, ANC >= 1.5×10?/L, PLT >= 80×10?/L, Hb >= 90 g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic growth factors for correction); b. Biochemistry criteria: serum albumin >= 3.0 g/dL (30 g/L), TBIL = 60 mL/min (Cockcroft-Gault formula); c. Adequate coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5×ULN; if the participant is receiving anticoagulant therapy, PT should be within the intended therapeutic range of the anticoagulant; 8. Ability to understand the informed consent form, sign the informed consent form, and willingness to comply with scheduled follow-up.
Exclusion criteria
Exclusion criteria: 1. Head and neck metastatic tumors, or non-salivary gland cancers such as sarcoma, squamous cell carcinoma, nasopharyngeal carcinoma, etc.; 2.Known allergy to the study drug, its active ingredient, or any excipients; or history of severe allergic reaction to other monoclonal antibodies; 3.Pregnant or breastfeeding female patients; or women of childbearing age with a positive pregnancy test (serum or urine) within 7 days prior to enrollment, or those with a negative test who refuse to use effective contraception during the study and for 2 months after the last dose of study treatment; or male patients with a female partner of childbearing age who refuse to use effective contraception during the study and for 2 months after the last dose of study treatment; 4.Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, hematologic disease, or endocrine system disease that is uncontrolled; 5.HIV infection, active hepatitis B (HBV-DNA = 104 copies/ml), or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay) that is uncontrolled; 6.Within 6 months prior to enrollment, occurrence of any of the following that is uncontrolled: myocardial infarction, severe/unstable angina pectoris, NYHA class II or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure; 7.Patients with mental illness or a known history of substance abuse or drug addiction; 8.Patients unable to give consent or to provide the required amount of tumor tissue for the study; 9.Presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results; or any other condition that, in the investigator’s opinion, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of establishing patient-derived salivary gland cancer organoids and completing in vitro drug sensitivity evaluation;Proportion of organoid-based in vitro drug sensitivity tests that identify at least one sensitive drug regimen;Organoid growth inhibition rate (TGI);Progression-Free Survival (PFS);Overall Survival (OS);1-year and 2-year overall survival rate (OSR); | — |
Countries
China
Contacts
Public ContactHuiyong Zhu
First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed