Biliary tract cancer
Conditions
Interventions
Emotional distress group:NA
No-emotional distress group:NA
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, age 18-75 years, life expectancy >3 months; 2. ECOG physical status score (PS score) 0 or 1; 3. Child-Pugh score stage A; 4. BTC confirmed by histopathology, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; 5. Functional indexes of vital organs meet the following requirements: neutrophils >=1.5*10^9/L; platelets >=100*10^9/L; hemoglobin >=9g/dl; serum albumin >=3g/dl; thyroid-stimulating hormone (TSH) =60ml/min (calculated by Cockcroft-Gault formula); 6. Subjects with at least 1 measurable lesion (according to RECIST 1.1); 7. Non-lactating or pregnant women using contraception during or 3 months after treatment; 8. Giving informed consent.
Exclusion criteria
Exclusion criteria: 1. Pathologic diagnosis of potbellied carcinoma, hepatocellular carcinoma, mixed hepatocellular carcinoma, and other non-cholangiocellular carcinoma malignant tumor components; 2. Pre-existing or concurrent other malignancies, with the exception of adequately treated non-melanotic skin cancers, carcinoma in situ of the cervix, and papillary thyroid carcinoma; 3. History of any active or previously documented autoimmune disease, or history of a syndrome requiring systemic use of steroids or immunosuppressive drugs; 4. Uncontrollable co-morbidities (active infections requiring systemic therapeutic treatment, congestive heart failure, hypertension difficult to control with medication, angina pectoris, cardiac arrhythmias, interstitial lung disease, active tuberculosis, HBV DNA >2000 copies/ml, HCV RNA >1000, etc., after antiviral therapy); 5. Patients known to have tested positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS) 6. Received CTLA-4 or PD-1/PD-L1 targeted immunotherapy within 6 months; 7. Abnormal coagulation function (PT>14s), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 8. A history of esophagogastric fundus varices, clinically significant bleeding symptoms within 3 months prior to enrollment, or a clear tendency to bleed; 9. Known history of severe allergy to any monoclonal antibody, anti-angiogenic targeted agents, and platinum or gemcitabine; 10. Comorbid acute or chronic psychiatric disorders, or taking antidepressant/anxiety medications, or a history of psychotropic substance abuse, alcoholism, or drug addiction; 11. Other factors that, in the judgment of the investigator, may affect subject safety or compliance with the trial. For example, serious medical conditions (including psychiatric disorders) requiring comorbid treatment, serious laboratory test abnormalities, or other family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free-survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall survival;health-related quality of life questionnaire; | — |
Countries
China
Contacts
Public ContactShi Guoming
Zhongshan Hospital Fudan University
Outcome results
None listed