Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Without Indication for Local Curative Treatment
Conditions
Interventions
test group:iparomlimab and tuvonralimab Combined with Platinum-Containing Chemotherapy and Cetuximab
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with an age of > 18 years old (at the time of signing the informed consent form (ICF) )and no gender restriction; 2. Patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) without indication for local curative treatment, per the 8th edition staging system of the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC), with primary tumors located in the oral cavity, oropharynx, hypopharynx, or larynx; 3. No prior systemic treatment for recurrent/metastatic lesions; however, systemic treatment administered as part of multimodal therapy for locally advanced disease (including induction therapy, systemic treatment concurrent with radiotherapy, and adjuvant therapy) is permitted, provided that the time from completion of such treatment to study enrollment (as measured by the date of informed consent) is more than 6 months; 4. At least one measurable target lesion confirmed per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1); or measurable lesions with clear radiological progression after local treatment; and all such lesions are suitable for repeated and accurate measurement; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; Karnofsky Performance Status (KPS) of >= 80; and life expectancy of more than 3 months; 6. The function of organs such as the heart, brain, lungs and kidneys is normal, and meets the following criteria: Hematology: White blood cells (WBC) >= 4000/µL, Neutrophils (NEUT) >= 2000/µL, Hemoglobin (Hb) >= 90 g/dL, Platelets (PLT) >=100,000/µL; Liver Function: Bilirubin= 30 g/dL; Renal Function: Serum creatinine= 60 mL/min calculated according to the Cockcroft-Gault formula; Coagulation Function: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and International Normalized Ratio (INR)= 50% for the left ventricle. 7. Both male and female subjects should agree to use contraceptive measures during the study and within 6 months after the study ends; female subjects must have a negative serum or urine pregnancy test within 7 days before enrollment in the study, and must be non-lactating patients. 8. Subjects must provide informed consent for the study before the trial and voluntarily sign a written informed consent form. 9. Be willing and able to comply with scheduled follow-up visits, treatment plans, laboratory tests, and other study procedures;
Exclusion criteria
Exclusion criteria: 1. Has a history of severe hypersensitivity reactions to any component of CTLA-4 monoclonal antibody (mAb), PD-1 monoclonal antibody (mAb), or anti-EGFR monoclonal antibody (mAb). 2. Has a known or suspected autoimmune disease, including dementia and epileptic seizures. 3. Abnormal Coagulation Function: (Prothrombin Time [PT] > 16 seconds, Activated Partial Thromboplastin Time [APTT] > 53 seconds, Thrombin Time [TT] > 21 seconds, Fibrinogen [Fib] < 1.5 g/L), or presence of bleeding tendency, or receiving thrombolytic or anticoagulant therapy. 4. Severe heart disease, pulmonary dysfunction, or patients with cardiac function or pulmonary function at grade 3 or lower (including grade 3). 5. Patients whose laboratory test results do not meet the relevant criteria within 7 days before enrollment. 6. Has comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic or local use of corticosteroids at immunosuppressive doses, before enrollment. 7. HIV-positive patients; or patients with positive blood screening for chronic hepatitis C (Hepatitis C Virus [HCV] antibody positive). 8. Women of childbearing age with a positive pregnancy test, and lactating women. 9. Having had another malignant tumor within 3 years or currently having concurrent malignant tumors. The following two cases are eligible for enrollment: other malignant tumors treated with a single surgery and achieving 5 consecutive years of disease-free survival (DFS); and cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder cancer [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)]. 10. Adverse reactions caused by any previous treatment have not resolved to grade <=1 according to CTCAE Version 5.0 (except for toxicities that the investigator judges to be without safety risks, such as alopecia, hypothyroidism stabilized by hormone replacement therapy, and xerostomia caused by radiotherapy). 11. Progression of disease during or within 6 months after completion of systemic therapy for locally advanced disease (including induction therapy, concurrent chemoradiotherapy, and adjuvant therapy). 12. Prior receipt of immune therapeutic drugs targeting CTLA-4/PD-1 bispecific antibodies; however, patients who received no more than one type of immune checkpoint inhibitor (limited to PD-1, PD-L1, CTLA-4, etc.) for immune induction/concurrent/maintenance therapy during the locally advanced stage, had no recurrence/progression within 1 year after completing treatment, and actually received surgical resection or definitive radiotherapy/chemoradiotherapy may be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Objective Response Rate (ORR);Safety;Disease control rate (DCR; | — |
Countries
China
Contacts
Public ContactSong Qu
Guangxi Medical University Cancer Hospital
Outcome results
None listed