Locally Advanced Oral Squamous Cell Carcinoma
Conditions
Interventions
Reduced-dose chemotherapy group:none
Standard dosage chemotherapy group:none
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced (stage III-IVB) oral squamous cell carcinoma (OSCC) histologically or cytologically confirmed, including metastatic disease that has not received prior systemic therapy or recurrent disease not curable by local therapy, according to the 8th edition of the UICC/AJCC TNM staging system for head and neck cancer. 2. No distant metastases. 3. At least one measurable lesion must be present per RECIST 1.1 criteria 4. Male or female patients aged >=18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 6. Complete imaging and pathological data must be available. 7. Informed consent must be obtained.
Exclusion criteria
Exclusion criteria: 1. Concurrent malignant tumors in other organs. 2. Patients with distant metastases. 3. Pregnant or lactating patients. 4. Patients concurrently participating in other clinical studies. 5. Critically ill patients unable to complete study assessments. 6. Patients with communication barriers due to conditions such as confusion, aphasia, or intellectual disability, which impair normal responses. 7. Patients known to be allergic to potentially used chemotherapeutic agents. 8. Patients with evidence of other diseases, neurological or metabolic dysfunction, abnormal physical examination findings, or abnormal laboratory test results, suspected to be contraindicated for the study drug or posing a high risk of treatment-related complications. 9. Patients with a history of organ transplantation. 10. Patients with a history of autoimmune diseases or other conditions requiring long-term systemic use of corticosteroid medications or immunosuppressive therapy. 11. Other factors that, in the investigator’s judgment, may deem the subject unsuitable or affect their participation in or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Pathological Complete Response, pCR;Progression-free survival, PFS;overall survival, OS;Security Index;Evaluation of Quality of Life; | — |
Countries
China
Contacts
Public ContactZhu Lijun
Guangdong Provincial People's Hospital
Outcome results
None listed