Recurrent or metastatic squamous cell carcinoma of the head and neck that cannot be treated locally
Conditions
Interventions
Trial Group:Atezolizumab 5mg/kg on day 1, every 3 weeks
Cisplatin 75mg/m^2 (days 2+3) or Carboplatin AUC=5 (day 2), every 3 weeks
Fluorouracil 750mg/m^2 (days 2-6), every 3 weeks
Chemotherapy for 6 cycles, immunotherapy continued until disease progression or intolerable toxicity
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form. 2. Age>=18 years and =12 weeks. 4. Subjects with histologically and/or cytologically confirmed recurrent or metastatic HNSCC (according to 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. 5. No prior systemic anti-tumor therapy for recurrent or metastatic HNSCC. Note: Subjects who have previously received adjuvant/neoadjuvant chemotherapy with curative intent for non-metastatic disease, or definitive radiotherapy combined with chemotherapy or cetuximab/nimotuzumab for locally advanced disease, are eligible for this study if disease progression occurs >6 months after the completion of the last treatment. 6. Have at least one measurable lesion according to RECIST v1.1, or a measurable lesion with confirmed radiological progression after local therapy, and the lesion is suitable for repeated and accurate measurement. 7. Good organ function: (1) Hematology (no blood components or cell growth factor support therapy used within 7 days prior to the first dose): 1) Absolute neutrophil count (ANC)>=1.5x10^9/L (1,500/mm^3); 2) Platelet count>=100x10^9/L (100,000/mm^3); 3) Hemoglobin > 90 g/L. (2) Renal function: 1) Serum creatinine =60 mL/min. (3) Hepatic function: 1) Serum total bilirubin (TBil)28 g/L. (4) Coagulation function: 1) International normalized ratio (INR) and activated partial thromboplastin time (APTT)=50%. 8. Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, with the serum result being definitive), and the test result must be negative. If a female subject of childbearing potential is sexually active with an unsterilized male partner, she must adopt an acceptable contraceptive method starting from the screening phase, and must agree to continue using this contraceptive method for 120 days after the last dose of the study drug. Whether to discontinue contraception after this time point shall be discussed with the investigator. 9. If an unsterilized male subject is sexually active with a female partner of childbearing potential, he must adopt an effective contraceptive method from the screening phase until 120 days after the last dose of the study drug. Whether to discontinue contraception after this time point shall be discussed with the investigator. 10. The subject is willing and able to comply with the scheduled visits, treatment regimens, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma with primary sites in the nasopharynx, nasal cavity, paranasal sinuses, salivary glands, thyroid or parathyroid glands, skin, or of unknown primary origin. 2. Subjects with skin ulcers at screening, or with superficial or protruding skin lesions that have excessive surface tension and a high risk of rupture, or those assessed by the investigator as having other potential risks of significant rupture. 3. Subjects with necrotic lesions who are assessed by the investigator as having a high risk of major bleeding if enrolled in the study. 4. Presence of brainstem, meningeal, or spinal cord metastases or spinal cord compression, or diagnosis of leptomeningeal disease; presence of active or untreated brain metastases, or brain metastatic lesions >= 1.5 cm in size, or anticipated requirement for cerebral radiotherapy within the first treatment cycle after randomization. 5. Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage. 6. Subjects with a history of prior immunotherapy, including any anti-tumor immunotherapy targeting immunological mechanisms of action such as immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, anti-CD47 antibodies, anti-SIRPa antibodies, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapies. 7. A history of or current non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy; or current presence of other pulmonary diseases including but not limited to pneumoconiosis, silicosis, drug-related pneumonia, and pulmonary diseases with severe lung function impairment; or acute exacerbation of chronic obstructive pulmonary disease (COPD) occurring within 1 month. 8. Active inflammatory bowel disease or a definite history of prior inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). 9. A history of severe bleeding tendency or coagulation dysfunction; presence of any symptoms or signs of active tumor bleeding within 6 months; presence of clinically significant bleeding symptoms within 1 month, including but not limited to gastrointestinal bleeding, hemoptysis (defined as expectoration or coughing up >= 1 teaspoon of fresh blood or small blood clots, or hemoptysis without sputum; subjects with blood-tinged sputum are eligible for enrollment), epistaxis (excluding nasal bleeding and post-nasal drip with blood); subjects with a history of or current long-term therapeutic anticoagulant therapy (e.g., atrial fibrillation patients with a CHADS2 score >= 2); receipt of continuous antiplatelet therapy within 10 days (e.g., aspirin > 325 mg/day, dipyridamole, ticlopidine, clopidogrel, cilostazol, etc.). 10. Receipt of non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factors, etc.; excluding IL-11 administered for the treatment of thrombocytopenia) within 2 weeks; receipt of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week. 11. A history of myocarditis, cardiomyopathy, or malignant arrhythmia. A history of unstable angina pectoris requiring hospitalization, myocardial infarction, congestive heart failure, or vascular diseases (e.g., aortic aneurysm at risk of rupture) within 12 months, or other cardiac impairments that may interfere with the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);1-Year and 2-Year Overall Survival Rates;Progression-Free Survival (PFS);Duration of Response (DoR);Disease Control Rate (DCR);Correlation between Tumor Tissue PD-L1 Expression and Prognosis and Treatment Efficacy; | — |
Countries
China
Contacts
Public ContactZheng Yun
The affiliated hospital of southwest medical university
Outcome results
None listed