Treatment for resectable intrahepatic cholangiocarcinoma using a combination of drugs and chemotherapy

A Single Arm, Exploratory Clinical Study on the Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC

This study is testing a new combination of drugs and chemotherapy to see if it can help people with resectable intrahepatic cholangiocarcinoma live longer and prevent the cancer from coming back after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (Academic / other)
• Drugs / interventions: Adebrelimab, Apatinib, chemotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06296563 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of a combination therapy involving Adebrelimab and Apatinib, along with HAIC, for patients with resectable intrahepatic cholangiocarcinoma. Participants will undergo neoadjuvant treatment for two cycles before surgery, followed by adjuvant therapy for up to one year post-surgery. The study seeks to improve patient survival rates and extend the time before cancer recurrence after surgical intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of resectable intrahepatic cholangiocarcinoma at stages Ib-IIIb.

Not a fit: Patients with serious complications, severe allergies, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance survival rates and reduce recurrence in patients with intrahepatic cholangiocarcinoma.

How similar studies have performed: While the specific combination of Adebrelimab and Apatinib is novel, similar approaches in treating cholangiocarcinoma have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* 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;
* 5\. Both men and women are eligible;
* 6\. The patient's Eastern Oncology Collaborative Group (ECOG) physical condition score is 0 or 1;
* 7\. No serious complications, such as hypertension, coronary heart disease, or history of mental illness, and no history of severe allergies; Non pregnancy and non lactation period;
* 8\. The organ and blood system functions of the subjects meet the following requirements:

  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
* 9\. The subjects can understand and sign the informed consent form to participate in the experimental study; Good compliance.
* 10\. Participants who have not undergone any local or systemic treatment for tumors in the past, and have undergone radical resection surgery for biliary tract cancer before recurrence for at least 2 years, can be included;
* 11\. Subjects with potential fertility need to use a medically approved contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within one month after the end of the study treatment period; And within 72 hours before enrollment, the serum or urine HCG test must be negative and must be non lactating;

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);
* 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;
* 5\. Serious infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or unexplained fever\>38.5 ° C occurred during screening/before the first administration;
* 6\. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
* 7\. Suffering from uncontrollable mental illness;
* 8\. The simultaneous occurrence of serious and/or uncontrollable diseases may affect the participation of the study, such as unstable angina pectoris, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, poorly controlled diabetes, serious activities, uncontrollable infection after insufficient biliary drainage (such as tumor blocking the bile duct);
* 9\. Pregnancy (positive pregnancy test) or lactation period;
* 10\. Other cancers that have occurred in the past (within the past 5 years) or simultaneously, excluding non melanoma skin cancer and in situ cancer;
* 11\. History of allergy or hypersensitivity to any investigational drug;
* 12\. Currently abusing alcohol or illegal drugs;
* 13\. Unable or unwilling to sign informed consent form.

Where this trial is running

Jinan, Shandong

• Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)

Conditions Intrahepatic Cholangiocarcinoma