Cholangiocarcinoma
Conditions
Interventions
Test group:Sintilimab, 200 mg, D1 administration, repeat at 21 days
The chemotherapy regimen selected by the investigator is a cycle every 21 days, with a total of 4-6 cycles. Patients who are given radiation therapy to the primary and/or metastatic lesions, and who a
Control group:Sintilimab, 200 mg, D1 administration, repeat at 21 days
The chemotherapy regimen selected by the investigator is a cycle every 21 days, with a total of 4-6 cycles. Maintenance therapy sintilimab, 200 mg, D1, repeated on 21 days.
Sponsors
Zibo Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Male or female>=18 years old, 3 months; 6. At least 1 measurable lesion according to RECIST1.1 criteria; 7. ECOG PS score of 0-1; 8. Adequate organ function, subjects need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) was >=1.5x10^9/L; 2) In the case of no blood transfusion in the past 14 days, platelet >=90×10^9/L; 3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; 4) Total bilirubin =60 ml/min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 8) 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; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 9. Patients with symptomatic brain metastases are allowed to enroll; 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 the 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: Subjects must not have any of the following 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. Histological or cytopathological confirmation of tumor combined with neuroendocrine and other components; 3. Current participation in interventional clinical study treatment, or treatment with other investigational drugs or investigational devices within 4 weeks prior to the first dose; 4. 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); 5. Those who have previously received palliative radiotherapy or postoperative adjuvant radiotherapy for biliary tract tumors; 6. Received systemic therapy with anti-tumor indications 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; 7. Active autoimmune disease requiring systemic treatment (such as 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 need to confirm the presence of autoimmune disease at the discretion of the investigator; 8. Systemic glucocorticoid therapy (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; 9. 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); 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Those who are known to be allergic to the active ingredient or excipient of the drug sintilimab in this study; 12. Have not recovered adequately from toxicity and/or complications caused by any of the interventions prior to initiation of treatment (i.e., < = Grade 1 or at 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 at the same time greater than the upper limit of normal in the laboratory of the research center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) 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; 2) for subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral loads (-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored; 15. Subjects with active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection); 16. Rec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of remission;Progression free survival;Safety;Overall survival; | — |
Countries
China
Contacts
Public ContactWang Qiang, Jia Mingguang
Zibo Municipal Hospital
Outcome results
None listed