Advanced biliary tract cancer
Conditions
Interventions
A:mFolfox6-HAIC (oxaliplatin 85mg/m2 d1, calcium folinate 400mg/m2d1, fluorouracil 400mg/m2d1 fast drops, fluorouracil 2400 mg/m2 for 46h, D1-3) + Tirellizumab 200mg (d1)
B:GC (gemcitabine 1000mg/m2 d1, 8, cisplatin 25mg/m2 d1, 8) + Tirellizumab 200mg (d1)
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18-80 years old; 2)ECOG score 0-2; 3) Patients with advanced or recurrent metastatic biliary system cancer (including gallbladder cancer, hilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, hepatocellular cholangiocarcinoma mixed type, etc.) who are not suitable for radical surgery (R0), non-radical surgery (R1) or palliative surgery, and who have not received systematic treatment in the past; 4) Have at least one measurable lesion according to RECIST version 1.1 evaluation criteria (maximum diameter of target lesion examined by spiral CT >= 10mm; If only lymph node metastasis, the minimum diameter should be >= 15mm); 5) Expected survival >= 12 weeks; 6) Liver function AST and ALT3×10^9/L, absolute granulocyte count >= 1.5×10^9/L; Platelet >= 75×10^9/L; Hemoglobin >= 80 g/L; Creatinine clearance >= 60ml/min; Total bilirubin <= 3 times the upper limit of normal (ULN); 7) To participate in the study voluntarily and sign the informed consent. If the subject is unable to read or sign, the informed consent shall be signed by the legal representative of the subject with the informed consent. For the subject who is unable to give consent, the above introduction and explanation shall be provided to the legal representative and the informed consent shall be signed by the legal representative; 8) Compliance was good, and the patient and his family agreed to cooperate with survival follow-up; 9) Women of reproductive age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last administration of the study drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the observation period and for 8 weeks after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1) Had received the following treatment before this study: a. Primary/recurrent patients who had previously received systemic therapy, except for recurrent patients who progressed after 6 months of prior adjuvant chemotherapy; b. The target lesion has been treated with radiotherapy and has not progressed; c. Participating in other therapeutic/interventional clinical trials; 2) Previously received PD-1, PD-L1, CTLA4 and other immunotherapy; 4) Known allergy to study drugs such as contrast agents or any of their excipients; Or have had a severe allergic reaction to other monoclonal antibodies; 5) Known uncontrolled or symptomatic active central nervous system (CNS) metastases; 6) Advanced patients who are symptomatic, have spread to the internal organs, and are at risk of developing life-threatening complications in the short term (including patients with uncontrolled large exudates [chest, pericardium, abdominal cavity]); 7) Had other active malignancies within 2 years prior to study entry. Except for skin basal cell carcinoma or squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, and thyroid papillary carcinoma that can be treated locally and has been cured; 8) The presence of any active autoimmune disease and long-term use of steroid hormones; 9) The presence of difficult-to-control diabetes; 10) Patients with infectious pneumonia, non-infectious pneumonia or interstitial pneumonia; 11) Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test positive, HBV-DNA >= 500 IU/ml and abnormal liver function; Hepatitis C, defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA above the lower detection limit of analytical methods, and abnormal liver function) or co-infection with hepatitis B and hepatitis C; 13) Patients with myocardial infarction, severe/unstable angina pectoris, NYHA grade II or higher cardiac dysfunction, and clinically significant supratrioventricular or ventricular arrhythmias requiring clinical intervention during the 6 months prior to study entry; Have poorly controlled hypertension (sustained systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100mmHg); 14) Systemic use of antibiotics for >= 7 days within 4 weeks prior to the first dose, or unexplained fever >38.5°C during the screening period/prior to the first dose (fever due to tumor, as determined by the investigators, can be included); 15) History or tendency of gastrointestinal bleeding, such as esophageal varices, locally active ulcer lesions, fecal occult blood >= (++) (gastroscopy is required when fecal occult blood is (+)), within 6 months prior to study entry; 16) Urinary protein >= ++ or 24-hour urinary protein >1.0g; 17) Inability to swallow the study drug, presence of chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis), and intestinal obstruction, among other factors that affect drug administration and absorption; 18) Pregnant and lactating women, subjects with reproductive capacity are unwilling to take effective contraceptive measures; 19) A clear history of neurological or psychiatric disorders, including epilepsy and dementia; A known history of psychotropic substance abuse or d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate, DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Progress free survival, PFS; | — |
Countries
China
Contacts
Public Contactjiahao pei
shanghai tongji hospital
Outcome results
None listed