Biliary Tract Cancer
Conditions
Interventions
Retrospective study group:Use PD-1
Prospective study group: Use PD-1
Sponsors
Shanghai Eastern Hepatobiliary Surgery Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) to obtain clinically selected patients with non-radical resection of gallbladder cancer (GBC) and intrahepatic cholangiocarcinoma (ICC); (2) GBC and ICC patients with clear histological/cytological diagnosis of gallbladder cancer or meeting clinical diagnostic criteria; (3) sergio based chemotherapy regimen, or combined targeted therapy, peritoneal heat perfusion chemotherapy or radiotherapy; (4) at least one measurable lesion (per RECIST 1.1); (5) patients aged 18-75 years with 0-1 ECOG score; (6) patients with child-pugh A or B grades of liver function have basically normal bone marrow function and renal function (evaluated within 7 days before medication); (7) expected survival time 2 months; (8) female and male patients of reproductive age need to take effective contraceptive measures; (9) patients or clients voluntarily accept immunotherapy, participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) pathologically confirmed as patients with sarcoma and neuroendocrine tumor; (2) progressive patients who have received more than two systems of treatment; (3) patients who received any anti-tumor treatment within 2 weeks before enrollment; (4) patients with a history of other malignant tumors (except superficial skin cancer and localized low-grade malignant tumors); (5) patients with a history of liver transplantation or preparing for liver transplantation; (6) patients with autoimmune diseases, such as interstitial pneumonia, autoimmune myocarditis, hepatitis, etc.; (7) patients with hypertension, myocardial ischemia grade 1 or above, myocardial infarction, malignant arrhythmia (QT 480ms) or congestive heart failure grade I or above NYHA; (8) patients with severe infections that are difficult to control; (9) diabetic patients with poor blood glucose control (fasting blood glucose > 10mmol/L); (10) patients with urinary protein ++ or 24-hour urinary protein > 1g; (11) patients with arterial or venous thromboembolic events within six months, such as cerebrovascular accidents (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; (12) imaging suggested tumor involvement in important blood vessels or patients assessed by the researchers as likely to cause fatal bleeding during follow-up; (13) patients with high risk of bleeding such as anticoagulation therapy or variceal bleeding; (14) patients who participated in clinical trials of other anticancer drugs within 4 weeks before enrollment; (15) patients with a history of immune deficiency; (16) patients with a history of substance abuse or mental disorders that are difficult to control; (17) patients who cannot take drugs orally or cooperate with treatment; (18) according to the judgment of the researcher, patients with diseases that may seriously endanger their own safety or may affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival; | — |
Countries
China
Contacts
Public ContactXiao-qing jiang
Shanghai Eastern Hepatobiliary Surgery Hospita
Outcome results
None listed