Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab 5 mg/kg, intravenous infusion, Q3W
combined with chemotherapy: Albumin-bound Paclitaxel 260 mg/m2 and Nedaplatin 80 mg/m2.
Sponsors
Shandong Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–75 years; 2. Histologically or cytologically confirmed squamous cell carcinoma, previously untreated, with locally advanced Stage III or IV disease; 3.At least one measurable lesion meeting RECIST 1.1 criteria; 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 5.Females and males of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until at least 5 months (for females) or 7 months (for males) after the last dose of the study drug. Women of childbearing potential must not be pregnant or breastfeeding; 6.Signed informed consent form has been obtained.
Exclusion criteria
Exclusion criteria: Study participants will be excluded from this research if they meet any of the following criteria: 1. Previous receipt of radiotherapy, chemotherapy, cancer vaccines, or immunotherapy; 2. Previous systemic treatment for other malignancies; 3. Inability to undergo radical surgical resection or presence of distant metastasis; 4. Allergy to the investigational drug used in this study; 5. Current participation in other clinical trials; 6. Active or historically documented autoimmune or inflammatory disorders (including inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis syndrome, rheumatoid arthritis, pituitary inflammation, uveitis, etc.). Exceptions include: vitiligo or alopecia, hypothyroidism (e.g., secondary to Hashimoto's syndrome) stable under hormone replacement therapy, any chronic skin condition not requiring systemic treatment, or celiac disease controlled by diet alone; 7. Uncontrolled comorbidities, including but not limited to: persistent or active infections (including tuberculosis), uncontrolled hypertension (defined as blood pressure >140/90 mmHg during screening despite pharmacological management), interstitial lung disease, severe chronic gastrointestinal disorders associated with diarrhea, or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events, or impair the patient's ability to provide written informed consent; 8. Untreated active hepatitis B infection (hepatitis B surface antigen [HBsAg] positive and hepatitis B virus DNA >=1000 IU/mL). Patients with past or resolved hepatitis B infection (defined as presence of hepatitis B core antibody [anti-HBc] with absence of HBsAg) are eligible. Active hepatitis C infection (hepatitis C antibody positive with hepatitis C virus RNA above the lower limit of detection); 9. Primary brain tumors (except meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizures uncontrolled with standard medications, or history of stroke within one year prior to the first dose of the investigational drug; 10. History of active primary immunodeficiency; 11. Positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 12. Use of immunosuppressive medications within 14 days prior to the first dose of the investigational drug. Exceptions include: nasal, inhaled, topical corticosteroids, or local steroid injections (e.g., intra-articular injection). Systemic corticosteroids at physiological doses not exceeding 10 mg prednisone or equivalent per day; 13. Administration of live attenuated vaccines within 30 days prior to the first dose of the investigational drug. Note: If enrolled, patients should not receive live vaccines during the treatment period and for at least 30 days after the last dose of the investigational drug; 14. Treatment with systemic immunostimulants within 14 days prior to the first dose of the investigational drug; 15. History of severe systemic diseases, including myocardial infarction or unstable angina within 12 months prior to the first dose of the investigational drug, hypertensive crisis or hypertensive encephalopathy, heart failure of New York Heart Association (NYHA) Class II or higher, unstable arrhythmias requiring medication, significant vascular disease, or symptomatic peripheral vascular disease; 16. History of coagulopathy, bleeding tendency, or thrombosis within 12 months prior to the first dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response, pCR;Major Pathological Response, mPR; progression-free survival, PFS;overall survival, OS;safety; | — |
Countries
China
Contacts
Public ContactWei Yumei
Shandong Second Provincial General Hospital
Outcome results
None listed