intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Chemotherapy combined with sindilizumab neoadjuvant therapy
Sponsors
Affiliated Hospital of Yunnan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed as ICC by preoperative imaging and postoperative histopathology; 2. The imaging assessment is initially resectable, that is, the lesion is limited to one side of the liver, the remaining functional liver volume ratio (FLR/SLV) is greater than 40%, the ICG 15R is less than 10%, and the inflow and outflow tract of the healthy liver can be preserved; 3. There is at least one high-risk recurrence risk factor, including: larger tumor diameter (>5cm), multiple tumors (>3), vascular invasion, lymph node metastasis and local invasion. 4. Have not received surgery (including local ablation), chemotherapy, targeted, immunotherapy and radiotherapy before. 5. No obstructive jaundice and blockage of large vessels (main portal vein and inferior vena cava). 6. The patient's gender is not limited, aged 18 to 75 years; the life expectancy is > 3 months. 7. ECOG PS score of 0 or 1 within 1 week of enrollment. 8. No serious comorbidities, such as hypertension, coronary heart disease and mental illness history, no serious allergic history; women of childbearing age must undergo a pregnancy test within 7 days before enrollment. 9. The patient's organs and blood system function meet the requirements: (1) Blood system function: 1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; 2) Platelet count >= 100 x 10^9/L; 3) Lymphocyte percentage >= 10%; (2) Renal function: Estimated glomerular filtration rate or creatinine clearance > 50 mL/min/1.73 m2; (3) Liver function: 1) Total bilirubin <= 2 x ULN; 2) AST and ALT <= 2 x ULN; 3) Child-pugh A grade; (4) HBV DNA < 2000 IU/ml (103 copies/ml) initially or after treatment. 11. The patient can understand and sign the informed consent form to participate in the trial study; can follow up with good compliance.
Exclusion criteria
Exclusion criteria: 1. No clear histopathological diagnosis was obtained before surgery to confirm ICC, or it was considered to be mixed liver cancer and other liver malignancies; 2. The preoperative assessment was initially unresectable, that is, the lesions were scattered in the whole liver, FLR/SLV 20%, and the inflow and outflow tract of the contralateral liver was invaded or blocked; 3. Preoperative assessment has distant metastasis; 4. There are no high-risk recurrence factors, that is, the TNM stage is T1a (single, diameter 2 points, NRS2002 score > 2 points; 8. In the past (within 5 years) or at the same time suffering from other uncured malignant tumors, including cured skin basal cell carcinoma and cervical carcinoma in situ; 9. The patient has received other major surgical operations within 2 weeks before enrollment; 10. Patients with CNS metastases or known brain metastases; past and present patients with objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc. ; Co-infected patients; Pregnant or lactating patients; Patients preparing for liver transplantation (except for patients with previous liver transplantation). 11. Suffering from myocardial ischemia or myocardial infarction of grade II or above, and poorly controlled arrhythmia (including QTc interval >= 450 ms for men and >= 470 ms for women); 12. Those who have a history of gastrointestinal bleeding within the past 6 months or have a clear tendency to gastrointestinal bleeding, such as esophageal varices with bleeding risk, locally active ulcer lesions, and fecal occult blood >= (++) are not eligible for inclusion; Gastroscopy is required if fecal occult blood (+); 13. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency or receiving thrombolytic or anticoagulation therapy; 14. The patient suffers from any clinically significant disease or has a history of such a disease that the investigator believes may jeopardize the safety of the patient or the reliability of the research results; 15. Systemic failure, expected survival time <3 months; 16. The treatment plan could not be completed due to various reasons, and the patient was lost to follow-up within three months after enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival;pathological complete response rate;major pathological response rate;objective response rate;security; | — |
Countries
China
Contacts
Public ContactZhao Jian
Affiliated Hospital of Yunnan University
Outcome results
None listed