intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Gemcitabine + cisplatin + Precision radiotherapy + Slulimumab
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Cholangiocarcinoma confirmed by histology/cytology. 2) The included patients were patients with first-line intrahepatic cholangiocarcinoma treated with GC (gemcitabine + cisplatin) and radiotherapy combined with slulimumab. All lesions are required to be eligible for RT treatment, and at least one of them is evaluable. 3) Liver function Child-Pugh class A, other laboratory tests: 1. Neutrophils =1.5×109/L 2. Platelets =75×109/L 3. Hemoglobin =90g/L (no blood transfusion record within 2 weeks or no dependence on erythropoietin (EPO)) 4. Serum creatinine =1.0 times ULN or calculated creatinine clearance = 60 ml/min (Cockcroft-Gault formula) 5. AST =2.5×ULN, ALT =2.5×ULN; if intrahepatic lesions are present, ALT and AST =5×ULN 6. TSH, FT3, FT4 within ± 10% of normal values 7. Coagulation function: international normalized ratio (INR) = 2 times ULN, and activated partial thromboplastin time (APTT) = 1.5 times ULN 4) ECOG score 0-1 points. 5) Expected survival time > 3 months. 6) No history of radiation therapy. 7) Age =18 years old and =75 years old. 8) Sign the informed consent form and be able to comply with the visits and related procedures stipulated in the plan. 9) Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age must take effective contraceptive measures during the entire treatment period and for 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1) Histology includes components such as hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, and sarcomatoid hepatocellular carcinoma. 2) Have a history of hepatic encephalopathy or liver transplantation. 3) Pleural effusion, ascites, and pericardial effusion with clinical symptoms or needing drainage, only imaging shows a small amount of pleural effusion, ascites, and pericardial effusion and are asymptomatic and can be selected. 4) People with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA>103 copies/ml; hepatitis B Surface antigen (HbsAg) and anti-HCV antibodies were positive at the same time. 5) Central nervous system metastasis. 6) History of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease, or extensive intestinal resection (partial colectomy or extensive small bowel resection) within the past 6 months , complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. 7) History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia or active pneumonia. Radiation pneumonitis within the radiation treatment area is permitted. 8) Active tuberculosis (TB), currently receiving anti-tuberculosis treatment or those who have received anti-tuberculosis treatment within 1 year before the first dose. 9) People infected with human immunodeficiency virus (HIV) (HIV 1/2 antibody positive). 10) Severe infection in active stage or with poor clinical control. Severe infection within 4 weeks before first dose, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia. 11) Active autoimmune diseases that require systemic treatment or a history of the disease within the past 2 years (vitiligo, psoriasis, alopecia or Grave's disease that does not require systemic treatment within the past 2 years, only thyroid hormone is required Patients with hypothyroidism requiring replacement therapy and patients with type I diabetes requiring only insulin replacement therapy are eligible). Known history of primary immunodeficiency. Patients who are only positive for autoimmune antibodies need to confirm whether there is an autoimmune disease according to the researcher's judgment. 12) Use of immunosuppressive drugs within the past 4 weeks, excluding topical glucocorticoids by nasal spray, inhalation or other routes or systemic glucocorticoids at physiological doses (i.e. not exceeding 10 mg/day of prednisone or other (other glucocorticoids at effective doses), and the temporary use of glucocorticoids for the treatment of dyspnea symptoms in diseases such as asthma and chronic obstructive pulmonary disease is allowed. 13) Have received live attenuated vaccines within the past 4 weeks or plan to during the study period. 14) Have received systemic immunostimulant treatment within the past 4 weeks. 15) Received major surgical surgery (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within the past 4 weeks. 16) Uncontrolled metabolic disorders or other non-malignant tumor organs or systemic diseases or secondary reactions to cancer, which may lead to higher medical risks and/or uncertainty in survival evaluation. 17) Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory test values t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP;ORR;DCR;Safety; | — |
Countries
China
Contacts
Public ContactDu Shisuo
Zhongshan Hospital, Fudan University
Outcome results
None listed