head and neck squamous cell carcinoma
Conditions
Interventions
exprimental group:SHR-1701, albumin paclitaxel, and carboplatin
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, gender is not limited; 2. According to histological or cytology confirmation, refer to the AJCC 8th edition guidelines, patients with unresectable advanced/recurrent/metastatic head and neck squamous cell carcinoma (stage III/IV/recurrence), and are not suitable for radical local therapy; 3. Previous >=1-line systematic antineoplastic therapy (for patients with recurrent disease, recurrence or metastasis that occurs during or within 6 months after receiving neoadjuvant or adjuvant therapy should be recorded as first-line therapy); 4. The toxicity of the previous treatment has been restored to level =1 (if there is surgery, the wound has completely healed); 5. ECOG score of 0-1; 6. Estimated survival>= 12 weeks; 7. The function of major organs and bone marrow is basically normal: (1) Blood routine: WBC >= 3500/mm3(3.5*10^9/L); neutrophil count (ANC>=1800/mm3 (1.8*10^9/L); Platelet count>= 100000/mm3 (100*10^9/L); hemoglobin>= 9.0g/dL (90g/L); (2) Blood biochemistry: Total bilirubin <=1.5*ULN (Gilbert syndrome total bilirubin < 3.0 mg/dL); Glutamate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) and alkaline phosphatase <= 2.5*ULN; creatinine <=1.5*ULN (AST/ALT<=5*ULN is allowed if liver metastases are present); (3) Coagulation function: The international normalized ratio (INR) is <= 1.5 (or 2-3 when the patient is taking fawarin stably for a long time) and the prothrombin time (PT) is <= 1.5*ULN; (4) Cardiac function test: Baseline ECG shows no PR interval prolongation or AV block; 8. Women should agree to use contraception (e.g., IUD, pill or condom) during the study and for 3 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should agree to use contraception during the study period and for 3 months after the end of the study period; 9. Patients voluntarily join the study, sign informed consent, have good compliance, and can be followed up by trial staff.
Exclusion criteria
Exclusion criteria: 1. Have had other active malignancies within 5 years prior to entering the study. except for cured basal cell carcinoma of the skin or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma of the breast, and papillary thyroid carcinoma; 2. Have received the following treatments or medications prior to the first study treatment: a) major surgery within 28 days prior to the first study drug treatment (tissue biopsy required for diagnosis is permitted); b) receive antineoplastic therapy within 28 days prior to the first study drug treatment, or no more than 5 half-lives from the last antineoplastic medication; c) have participated in any other drug clinical study within 4 weeks prior to the first dose; d) receive live attenuated vaccine within 28 days prior to the first study drug treatment or planned to receive live attenuated vaccine during the study period and within 60 days after the end of study drug treatment; e) previous use of albumin paclitaxel or carboplatin and progression within 3 months after the end of medication; 3. Systemic antibiotic use within 4 weeks before the first dose for >=7 days, or unexplained fever of 38.5 degree during screening/before the first dose (fever due to tumor causes can be enrolled according to the judgment of the investigator); 4. Any previous history of activity or history of autoimmune disease (including any history of inflammatory bowel), or a history of syndrome requiring systemic steroid or immunosuppressive therapy, except for vitiligo or childhood asthma/allergic diseases; 5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6. Patients with any severe and/or uncontrolled medical conditions, such as: a) unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; Patients with suboptimal blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg). b) Active or uncontrolled severe infection; c) Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; d) poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); e) Urinalysis suggests urine protein >=++, and it is confirmed that the 24-hour urine protein quantification is > 1.0g; 7. Known uncontrollable or symptomatic active central nervous system (CNS) metastases; 8. Have had clinically significant active bleeding (such as gastrointestinal bleeding, etc.) within 2 months before the first dose, or are taking anticoagulant drugs (such as warfarin, phenprocoumarin, prophylactic use of low-dose aspirin, low molecular weight heparin), or the investigator judged that there is a clear high-risk bleeding tendency during the screening period (such as esophageal varices with bleeding risk, local active ulcer foci, positive fecal occult blood cannot exclude gastrointestinal bleeding, intermittent hemoptysis, etc.); 9. Chest imaging during screening showing suspected interstitial lung disease (ILD) or pulmonary fibrosis or lung inflammation requiring treatment; or a history of lung disease treated with oral or intravenous steroids within 6 months prior to first use, or immune-related pneumonia following prior treatment with immune checkpoint inhibitors; 10. There are obvious gastrointestinal abnormalities during the screening period, which may affect the intake, transport or absorpti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival;disease control rate;duration of response;safety; | — |
Countries
China
Contacts
Public ContactXin Liu
Fudan University Shanghai Cancer Center
Outcome results
None listed