Patients with head and neck squamous cell carcinoma (HNSCC) who develop locoregional recurrence after curative treatment, with recurrent tumors amenable to local therapy
Conditions
Interventions
Trial group:Tislelizumab in combination with Cetuximab
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in this study and has signed the informed consent form. 2. Male or female patients aged 18–75 years. 3. Histologically or cytologically confirmed head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma, nasal cavity, paranasal sinus, and salivary gland tumors. 4. Patients with isolated recurrence who have undergone salvage surgery and/or radiotherapy (including re-irradiation), with clinical assessment indicating a favorable response, defined as complete response (CR) or major partial response (tumor shrinkage >90%). 5. If previously treated with immune checkpoint inhibitors and/or cetuximab, patients must have discontinued treatment for at least 3 months prior to recurrence. 6. Eastern Cooperative Oncology Group (ECOG) performance status score =90 g/L; Note: Patients must not have received transfusions or growth factor support within 14 days prior to screening blood draw. 2) Absolute neutrophil count (ANC) >=1.5×10^9/L (1500/mm^3); 3) Platelet count (PLT) >=100×10^9/L; 4) International Normalized Ratio (INR) or prothrombin time (PT) =24 weeks.
Exclusion criteria
Exclusion criteria: 1. History of autoimmune disease, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Note: Patients with vitiligo, type 1 diabetes, residual hypothyroidism due to autoimmune disease following Hashimoto’s syndrome requiring only hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions predicted not to recur in the absence of external triggers are eligible.) 2. Patients with active brain or meningeal metastases; 3. Patients with squamous cell carcinoma of unknown primary origin; 4. Patients with malignancy diagnosed within the past 3 years that has not been controlled; 5. Patients with a history of primary immunodeficiency or allogeneic organ transplantation; 6. Use of anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any other antibodies or drugs targeting T-cell co-stimulation or immune checkpoint pathways prior to treatment; 7. Administration of live attenuated vaccines within the past 30 days; 8. Patients with untreated and/or uncontrolled cardiovascular disease and/or symptomatic cardiac dysfunction (including unstable angina, congestive heart failure, myocardial infarction within the past year, ventricular arrhythmias requiring pharmacologic treatment, or history of second- or third-degree atrioventricular block). In patients with a history of significant cardiac disease, even if controlled, LVEF must be >=50% within 12 weeks prior to immunotherapy; 9. Severe liver injury (total bilirubin >3×ULN and any AST elevation); 10. Patients with interstitial lung disease; 11. Pregnant or lactating women; 12. All toxicities related to prior anticancer therapy must have resolved to grade 1 (NCI CTCAE v4) or baseline level prior to dosing; patients who have received prior anticancer therapy and are expected to have persistent, long-term sequelae from toxicity (e.g., peripheral neuropathy following platinum-based therapy) are eligible; 13. Physical and laboratory test results: a) Positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus RNA (HCV RNA), indicating acute or chronic infection; b) Known positive history for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); c) Any grade 4 laboratory abnormality; 14. Allergy and drug adverse reactions: History of allergy to any drug component; history of severe hypersensitivity reaction to any monoclonal antibody; 15. Presence of active severe clinical infection, including active tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Adverse effect; | — |
Countries
China
Contacts
Public ContactHua yonghong
Zhejiang Cancer Hospital
Outcome results
None listed