biliary tract cancer
Conditions
Interventions
test group:Chidamide + camrelizumab + S-1 ± albumin paclitaxel
Sponsors
First affiliated hospital of Soochow university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: a. Pathologically confirmed biliary tract malignancy; b. age =18 years old, both sexes; c. Expected survival time =3 months; d. ECOG score 0-1; e. At least one measurable lesion, according to iRECIST criteria; f. Second-line therapy, progression or intolerance after previous first-line therapy, and no previous S-1 based chemotherapy; g. The main organ function is good, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: Hemoglobin = 90 g/L (no blood transfusion within 14 days); Neutrophil count > 1.5×109/L; Platelet count = 100×109/L; Total bilirubin = 1.5×ULN (upper limit of normal); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5×ULN; If there was liver metastasis, ALT or AST = 5×ULN; Endogenous creatinine clearance = 60 ml/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%; h. signed the informed consent form with good compliance, and the family members agreed to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: a. previous or concurrent other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Patients with small gastric stromal tumor and other tumors, and other early tumors after radical treatment, and other tumors that do not affect the patient's life in the short term according to the investigator's judgment can be excluded. b. participated in other drug clinical trials within four weeks; c. Patients with known CNS metastases or a history of CNS metastases prior to screening. Patients with clinically suspected central nervous system metastases had to undergo CT or MRI within 28 days before enrollment to rule out central nervous system metastases. d. A history of unstable angina pectoris; Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTcF =450 ms in men and =470 ms in women) required long-term use of antiarrhythmic drugs and New York Heart Association (NYHA) grade =II cardiac dysfunction. e. Urine routine test showed urinary protein =++ and confirmed 24-hour urinary protein quantification > 1.0 g; f. For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests had to be negative within 7 days prior to study enrollment, and they had to be nonlactating. Male subjects: patients who should be surgically sterilized or who have agreed to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period; g. a history of immunodeficiency or other acquired or congenital immunodeficiency disease or organ transplantation; h. Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; i. a history of chronic autoimmune diseases such as systemic lupus erythematosus; He had a history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, and a history of chronic diarrhea such as irritable bowel syndrome. A history of sarcoidosis or tuberculosis; Patients with a history of active hepatitis B or C, and HIV infection; j. Patients with hypersensitivity to human or murine monoclonal antibodies; k. those who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders; l. Pleural or peritoneal effusions with clinical symptoms requiring clinical intervention; m. Concomitant diseases that, in the judgment of the investigator, seriously compromise patient safety or prevent the patient from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;6 months progression free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;progressives free survival, PFS;overall survival, OS;6 months overall survival rate;12 months progression free survival rate;12 months overall survival rate;disease control rate, DCR;quality of life, QoL;nutrition score PG-SGA; | — |
Countries
China
Contacts
Public ContactWei Li; Kai Chen; Lei Qin
First Affiliated Hospital of Soochow University
Outcome results
None listed