Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Adebelimumab + gemcitabine, cisplatin systemic chemotherapy + SBRT
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. 18 years old 5 cm; Number of tumors> = 3 or combined satellite foci; portal vein or hepatic vein invasion; regional lymph node metastases; Preoperative CA199>200U/ml; After expert discussion, under the premise of ensuring liver function and sufficient residual liver volume, the width of the resection margin was less than 10 mm 4. At least 1 measurable lesion according to RECIST1.1 criteria; 5. ECOG PS score of 0-1; 6. 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) was >=1.5x10^9/L; In the absence of blood transfusion in the past 14 days, platelet >=90×10^9/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 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); 7. 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; 8. 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. Diagnosis of other malignant diseases outside the biliary tract within 5 years before the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection) 2. Currently participating in interventional clinical study treatment, or having received other investigational drugs or used an investigational device within 4 weeks prior to the first dose 3. Prior treatment with the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors (e.g., CTLA-4, OX-40, CD137). 4. Previous palliative radiotherapy for biliary tract tumors, except for postoperative adjuvant radiotherapy. 5. Received systemic systemic therapy with anti-tumor indications of proprietary Chinese medicines or immunomodulatory drugs (including thymus peptide, interferon, interleukin, except for topical use for the control of pleural effusion) within 2 weeks before the first dose 6. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy. Known history of primary immunodeficiency. Patients with only positive autoimmune antibodies should be confirmed for the presence of autoimmune disease at the discretion of the investigator 7. Is receiving systemic glucocorticoids (excluding nasal, inhaled, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks prior to the first dose of the study Note: Physiologic doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) are allowed 8. Presence of clinically uncontrollable pleural effusion/ascites effusion (patients who do not need to drain the effusion or stop draining for 3 days without significant increase in effusion can be enrolled) 9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation 10. Those who are known to be allergic to the active ingredient or excipient of the drug ivoximab in this study 11. Have not recovered adequately from toxicity and/or complications induced by any intervention prior to initiation of treatment (i.e., <=Grade 1 or at baseline, excluding fatigue or alopecia) 12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive) 13. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected at the same time greater than the upper limit of normal in the laboratory department of the study center) Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: HBV viral load < 2.5×10^3 copies/ml (500 IU/ml) before the first dose, and subjects should receive anti-HBV therapy throughout the study treatment period Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy, but close monitoring for viral reactivation is required 14. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection) 15. Vaccination with live attenuated vaccine within 4 weeks prior to the first dose 16. Pregnant or lactating women 17. Presence of any severe or uncontroll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year Progression-free survival;Main pathological remission, MPR;Disease control rate DCR;Pathologic complete response, PCR;Relapse free survival, RFS;R0 resection rate;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactWentao Wang
West China Hospital, Sichuan University
Outcome results
None listed