biliary tract cancer
Conditions
Interventions
Experimental Group:HAIC+ICIs
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >18 years old, male or female; 2.Diagnosed with unresectable biliary tract cancer (including gallbladder cancer, intrahepatic cholangiocarcinoma, hepatoportal cholangiocarcinoma) confirmed by pathological histology/cytology; 3. No systemic and interventional therapy (including therapeutic TACE, TAE, HAIC, TARE, etc.), = 6 cycles of neoadjuvant and/or adjuvant therapy allowed for inclusion. 4. Refusal of intravenous chemotherapy and tumour lesions confined to the abdominal cavity. 5. Child-Pugh score = 7 for patients with comorbid cirrhosis and ALBI = 2 for patients without comorbid cirrhosis. 6.A measurable tumour target lesion (according to RECIST 1.1 criteria); 7. Expected survival > 3 months; 8. ECOG PS: 0-1 points; 9. Normal function of major organs; a) Routine blood tests: Haemoglobin (Hb) = 90g/L; Absolute neutrophil count (ANC) = 1.5 x 10^9 /L; Platelet (PLT) = 75 x 10^9 /L; White blood cell count (WBC) = 3.0 x 10^9 /L; b) Biochemical tests: Albumin transaminase (ALT) and albumin transaminase (AST) = 5 × ULN; serum total bilirubin (TBIL) = 3 × ULN; serum creatinine (Cr) = 1.5 × ULN or creatinine clearance = 50 ml / min; c) Coagulation function: Activated partial thromboplastin time (APTT), International Normalised Ratio (INR), Prothrombin Time (PT) = 1.5 x ULN; 10. Women of childbearing potential must undergo a negative pregnancy test (ßHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose; 11. Participants voluntarily enrolled in this study by signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Concurrent other malignancies (mixed hepatocellular carcinoma-cholangiocarcinoma should also be excluded) 2. Prior treatment against PD-1/PD-L1 targets and/or CTLA-4 targets (except =6 cycles of neoadjuvant and/or adjuvant therapy); 3. Known history of allergy to any of the investigational drugs; 4. Autoimmune disease and requiring hormonal therapy above 10 mg prednisone/day (or equivalent dose). 5. Active pulmonary infection; 6. History of live attenuated vaccination within 28 days prior to the first study dose or expected live attenuated vaccination during the study period; 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 8. Previous or intended allogeneic bone marrow or solid organ transplantation; 9. Uncontrolled hypertension with medications, Class III-IV cardiac insufficiency (NYHA criteria); 10. Active bleeding, active ulcers, intestinal perforation, intestinal obstruction, within 30 days of major surgery; Previous history of definite neurological or psychiatric disorders, including epilepsy or dementia, and subject has a known history of psychotropic substance abuse, alcoholism, or drug addiction; 11. Any other conditions which in the opinion of the investigator make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Duration of response;Overall survival;Disease control rate;Safety;Biliary obstruction response; | — |
Countries
China
Contacts
Public ContactWenheng Zheng
Liaoning Cancer Hospital & Institute
Outcome results
None listed