Esophageal and headneck squamous cell carcinoma
Conditions
Interventions
Cohort 1:SHR6390+SHR1020
Cohort 2:SHR6390+Cetuximab
Cohort 3:SHR6390+Fluzoparib
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.18-75 years old, male or female; 2. ECOG score 0-2; 3. Patients with advanced esophageal squamous cell carcinoma or head and neck squamous cell carcinoma who have failed in previous immunotherapy; 4. According to the evaluation criteria for solid tumor remission (RECIST 1.1), there is at least one measurable lesion; 5. Expected survival time = 12 weeks; 6. The functions of main organs and bone marrow are normal, meeting the following requirements: a. Hemoglobin = 90 g/L; (No blood transfusion within 14 days); b. Absolute neutrophil count = 1.5 × 109/L c. Platelet count = 90 × 109/L d. Total bilirubin = 1.5 times the upper limit of normal value (ULN); e. ALT and AST = 2.5 times ULN; If liver metastasis exists, ALT and AST = 5 times ULN; f. Creatinine = 1.5 times ULN; g. Left ventricular ejection fraction (LVEF) = 50%; QTc: male < 450ms, female < 470ms; 7. International normalized ratio (INR) of prothrombin time = 1.5, partial thromboplastin time (APTT) = 1.5 times ULN in patients who have not received anticoagulation treatment. For patients receiving full dose or parenteral anticoagulant treatment, the dose of anticoagulant should be stable for at least 2 weeks before entering the clinical study, and the results of coagulation test should be within the limits of local treatment; 8. Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; For men, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; 9. The toxicity of the previous treatment has recovered to = 1 level (if there is surgery, the wound has completely healed); 10. The patient voluntarily participated in and signed the informed consent form. It is expected that the patient has good compliance and can cooperate with the study according to the requirements of the scheme.
Exclusion criteria
Exclusion criteria: 1. Have received any anti-tumor treatment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial within 4 weeks before enrollment; 2. They received surgery within 4 weeks before enrollment (except for minor outpatient surgery, such as placing vascular access); 3. There is a third space effusion with clinical symptoms that cannot be controlled by drainage or other methods (such as a large amount of pleural effusion or ascites); 4. Even after drug treatment, hypertension was still poorly controlled (systolic blood pressure continued to rise = 150 mmHg or diastolic blood pressure = 100 mmHg); 5. Accompanied with uncontrollable cardiac clinical symptoms or diseases, such as (1) NYHA Grade II and above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular or ventricular arrhythmia with clinical significance and requiring clinical intervention; 6. People with congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method) or people with co infection of hepatitis B and hepatitis C; 7. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 2 weeks before the first drug administration, or fever of unknown cause>38.5 ° C occurred during screening/before the first drug administration; 8. Arterial/venous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 9. Suffered from or accompanied by other system malignant tumors in the last 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer); 10. People known to be allergic to any test drug; 11. Pregnant and lactating patients or patients with reproductive capacity are unwilling to take effective contraceptive measures; 12. Have a clear history of neurological or mental disorders, including epilepsy and dementia; 13. Known uncontrolled or symptomatic active central nervous system (CNS) metastasis, manifested by clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal diseases and/or progressive growth; 14. Patients unable to swallow the study drug, such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis), intestinal obstruction and other factors affecting drug administration and absorption; 15. Other situations that the researcher thinks are not suitable for inclusion. If it is accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactGuochun Cao
Jiangsu Cancer Hospital
Outcome results
None listed