The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are:
How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery.
Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.
1. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma;
2. According to the UICC/AJCC TNM staging system (8th edition, 2017), resectable subjects were classified as Ib-IIIb stages;
3. aged ≥ 18 years at the time of signing the Informed consent form (ICF);
4. Expected survival time>3 months;
1. Patients who received PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors before enrollment, or patients who directly received another stimulating or co inhibitory T cell receptor (such as CTLA-4, CD137);
2. Use any other investigational drugs within 4 weeks prior to enrollment;
3. Any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); Children with asthma who have completely improved in adulthood and do not require any intervention can be included, but patients who require intervention with bronchodilators cannot be included;
4. Congenital or acquired immunodeficiency, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml), hepatitis C (hepatitis C antibody positive, HCV-RNA above the detection limit of the analysis method), or co infection with hepatitis B and hepatitis C;
Single group
HAIC
Procedure/SurgeryFOLFOX-hepatic artery infusion for 2 times.
Adebrelimab
DrugAdebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most.
Apatinib
DrugApatinib 250mg, po, qd,q3w,up to one year of use at most.
Pathologic complete response (pCR)
The proportion of subjects whose postoperative pathological examination did not detect residual cancer cells.
Objective response rate (ORR)
Objective response rate
Event free survival (EFS)
The time from enrollment to the scheduled occurrence of events, including death, disease recurrence, disease progression, etc
Overall Survival (OS)
Overall Survival：The survival time from enrollment to death from any cause.
Disease Control Rate (DCR)
Disease Control Rate: Ratio of complete response (CR)+partial response (PR)+stable disease (SD)
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Lei ZHAO
Lead sponsor
Shandong Cancer Hospital and Institute
Sponsor institution
