Patients with head and neck malignant tumors (epithelial-origin malignant tumors: squamous cell carcinoma, adenocarcinoma, etc.
Conditions
Interventions
Cohort 3: Patients with recurrent head and neck malignancies who have a history of prior radiotherapy, have undergone curative surgery, or have undergone curative surgery with high-risk features (posi
Cohort 2: Patients with head and neck malignancies who have undergone palliative/salvage surgery and are planned to receive further systemic drug therapy, or those who are not suitable for surgery (du
Cohort 1: Patients with primary or recurrent resectable head and neck malignancies who are planned to enroll in relevant clinical trials and receive neoadjuvant drug therapy.:None
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with head and neck malignancies (epithelial-origin malignancies: squamous cell carcinoma, adenocarcinoma, etc.; mesenchymal-origin malignancies: sarcoma, osteosarcoma, etc.); 2. Tumor located in the oral, maxillofacial, and head and neck region (including oral cavity, oropharynx, larynx, hypopharynx, salivary glands, maxillary sinus, etc.); 3. Sufficient tumor tissue can be obtained for pathological diagnosis and in vitro organoid culture; 4. ECOG performance status: 0–3; 5. Major organ functions are normal and sufficient to tolerate chemotherapy, targeted therapy, or immunotherapy: baseline assessment or post-treatment criteria must meet the following: (1) Complete blood count: WBC >= 4.0 × 10^9/L, ANC >= 1.5 × 10^9/L, PLT >= 80 × 10^9/L, Hb >= 90 g/L (no blood or blood product transfusion or use of G-CSF or other hematopoietic growth factors within 14 days prior); (2) Biochemistry: serum albumin >= 3.0 g/dL (30 g/L), TBIL = 60 mL/min (Cockcroft-Gault formula); (3) Coagulation function: international normalized ratio (INR) or prothrombin time (PT) 3 months; Cohort 2: >3 months; Cohort 3: >2 years; 8. Capable of understanding the informed consent form, providing signed informed consent, and willing to comply with all required follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, hematologic disease, or endocrine disorder, with uncontrolled disease; 3. Patients infected with HIV, or with active hepatitis B (HBV-DNA >= 10^4 copies/mL), or hepatitis C (anti-HCV positive with HCV-RNA above the lower limit of detection of the assay), with uncontrolled disease; 4. History of any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina, NYHA class II or higher heart failure, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure, with uncontrolled disease; 5. Presence of psychiatric illness, or known history of substance abuse or drug addiction; 6. Known hypersensitivity to the study drug or any of its excipients; or history of severe allergic reaction to other monoclonal antibodies; 7. Patients unable to provide informed consent, or unable to obtain sufficient tumor tissue for pathological diagnosis and experimental purposes; 8. Presence of other serious physical or psychiatric conditions or laboratory abnormalities that may increase the risk of participation in the study, interfere with study outcomes, or as deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of establishing PDOs and completing in vitro drug sensitivity assessment.;Major pathological response rate;Progression-free survival;Growth inhibition ratio;Relapse-free survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| GI50;Overall survival rate of 2 years;GR50;IC50; | — |
Countries
China
Contacts
Public ContactHe Yue
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed