Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Tislelizumab + GemCis systemic chemotherapy + raltitrexed hepatic artery liver perfusion
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. 18 years old5cm in diameter; G. The tumor is close to the 1/2 grade branch of the liver pedicle, and R0 resection is difficult; H. Lymph node metastasis: MRI or PET/CT showed regional lymph node metastasis. 5. Those who have not received systemic therapy in the past, and are allowed to be enrolled in radical surgery or adjuvant therapy for more than 6 months; 6. Expected survival time> 6 months; 7. At least 1 measurable lesion according to RECIST1.1 criteria; 8. ECOG PS score of 0-1; 9. Adequate organ function, subjects need to meet the following laboratory indicators: In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) >= 1.5x109/L; In the case of no blood transfusion in the past 14 days, platelet >=90×109/L; Hemoglobin > 9 g/dL in the absence of blood transfusion or erythropoietin use in the past 14 days; Total bilirubin = 60 ml/min; Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; Cardiac enzyme spectrum within normal range (if the investigator comprehensively judges that the simple laboratory abnormality is not clinically significant, enrollment is also allowed); 10. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug;
Exclusion criteria
Exclusion criteria: 1.Other malignant diseases outside the biliary tract diagnosed within 5 years before the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ) 2. Ampullary tumor, gallbladder cancer, extrahepatic bile duct cancer, hepatocellular carcinoma, mixed cell carcinoma or fibrolamellar cell carcinoma and other malignant tumor components other than biliary tract cancer 3. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first dose 4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulatory or synergistic inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137) 5.Previously received palliative radiotherapy for biliary tumors, excluding postoperative adjuvant radiotherapy. 6.Systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose 7.Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic treatment. Known history of primary immunodeficiency. Patients with only positive autoimmune antibodies need to confirm whether they have autoimmune diseases based on the investigator's judgment 8. Receiving systemic glucocorticoid treatment (excluding topical glucocorticoids via nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 4 weeks before the first dose of the study Note: Physiological doses of glucocorticoids are allowed (<=10 mg/day of prednisone or equivalent) 9. Patients with clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need to drain the effusion or who do not have a significant increase in the effusion after cessation of drainage for 3 days can be enrolled) 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation 11.Known allergy to the active ingredient or excipients of the study drug tislelizumab 12.Have not fully recovered from any toxicity and/or complications caused by any intervention before starting treatment (i.e., = grade 1 or reaching baseline, excluding fatigue or alopecia) 13.Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive) 14.Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value of the laboratory department of the research center) Note: Hepatitis B subjects who meet the following criteria can also be enrolled: HBV viral load <2.5×103 copies/ml (500 IU/ml) before the first dose, the subject should receive anti-HBV treatment during the entire study treatment period For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), no preventive anti-HBV treatment is required, but close monitoring of viral reactivation is required 15.Active HCV infection subjects (HCV antibody positive and HCV-RNA level above the detection limit) 16. Va
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Disease control rate, DCR;Progression free survival, PFS;Overall survival, OS;Security;Proportion of complete pathologic remission; | — |
Countries
China
Contacts
Public ContactWentao Wang
West China Hospital, Sichuan University
Outcome results
None listed