Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC

Last updated: April 15, 2024
Sponsor: Lei ZHAO
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Abdominal Cancer

Biliary Tract Cancer

Treatment

Apatinib

HAIC

Adebrelimab

Clinical Study ID

NCT06296563
SHR1316-ICC-SD-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma;
    1. According to the UICC/AJCC TNM staging system (8th edition, 2017), resectablesubjects were classified as Ib-IIIb stages;
    1. aged ≥ 18 years at the time of signing the Informed consent form (ICF);
    1. Expected survival time>3 months;
    1. Both men and women are eligible;
    1. The patient's Eastern Oncology Collaborative Group (ECOG) physical condition scoreis 0 or 1;
    1. No serious complications, such as hypertension, coronary heart disease, or historyof mental illness, and no history of severe allergies; Non pregnancy and non lactationperiod;
    1. The organ and blood system functions of the subjects meet the followingrequirements:
  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9/L;
  2. Platelet count ≥ 75 × 10 ^ 9/L;
  3. Hemoglobin ≥ 90 g/L;
  4. Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN);
  5. Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN;
  6. Albumin ≥ 3g/dL
  7. Creatinine ≤ 1.5 x ULN
    1. The subjects can understand and sign the informed consent form to participate inthe experimental study; Good compliance.
    1. Participants who have not undergone any local or systemic treatment for tumors inthe past, and have undergone radical resection surgery for biliary tract cancer beforerecurrence for at least 2 years, can be included;
    1. Subjects with potential fertility need to use a medically approved contraceptivemeasure (such as an intrauterine device, contraceptive pill, or condom) during thestudy treatment period and within one month after the end of the study treatmentperiod; And within 72 hours before enrollment, the serum or urine HCG test must benegative and must be non lactating;

Exclusion

Exclusion Criteria:

    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);
    1. Use any other investigational drugs within 4 weeks prior to enrollment;
    1. Any history of active autoimmune diseases or autoimmune diseases (such asinterstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation,vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormonereplacement therapy); Children with asthma who have completely improved in adulthoodand do not require any intervention can be included, but patients who requireintervention with bronchodilators cannot be included;
    1. Congenital or acquired immunodeficiency, such as infection with humanimmunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml), hepatitis C (hepatitis C antibody positive, HCV-RNA above the detection limit of the analysismethod), or co infection with hepatitis B and hepatitis C;
    1. Serious infection (such as intravenous infusion of antibiotics, antifungal orantiviral drugs) occurred within 4 weeks before the first administration, orunexplained fever>38.5 ° C occurred during screening/before the first administration;
    1. History of allogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation;
    1. Suffering from uncontrollable mental illness;
    1. The simultaneous occurrence of serious and/or uncontrollable diseases may affectthe participation of the study, such as unstable angina pectoris, myocardialinfarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestiveheart failure, poorly controlled diabetes, serious activities, uncontrollableinfection after insufficient biliary drainage (such as tumor blocking the bile duct);
    1. Pregnancy (positive pregnancy test) or lactation period;
    1. Other cancers that have occurred in the past (within the past 5 years) orsimultaneously, excluding non melanoma skin cancer and in situ cancer;
    1. History of allergy or hypersensitivity to any investigational drug;
    1. Currently abusing alcohol or illegal drugs;
    1. Unable or unwilling to sign informed consent form.

Study Design

Total Participants: 20
Treatment Group(s): 3
Primary Treatment: Apatinib
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
March 01, 2029

Connect with a study center

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong 250117
    China

    Active - Recruiting

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