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

NCT ID: NCT06296563

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2029-03-01

Brief 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.

Conditions

Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HAIC+Adebrelimab+apatinib

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.

Group Type: EXPERIMENTAL

HAIC

Intervention Type: PROCEDURE

FOLFOX-hepatic artery infusion for 2 times.

Adebrelimab

Intervention Type: DRUG

Adebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most.

Apatinib

Intervention Type: DRUG

Apatinib 250mg, po, qd,q3w,up to one year of use at most.

Interventions

HAIC

FOLFOX-hepatic artery infusion for 2 times.

Intervention Type: PROCEDURE

Adebrelimab

Adebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most.

Intervention Type: DRUG

Apatinib

Apatinib 250mg, po, qd,q3w,up to one year of use at most.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lei ZHAO

OTHER

Sponsor Role: lead

Responsible Party

Lei ZHAO

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Lei Zhao, MD

Role: primary

drzhaolei@hotmail.com

+86 053167626368

Peifei Sun, MD

Role: backup

+86 053167626242

Other Identifiers

SHR1316-ICC-SD-001

Identifier Type: -

Identifier Source: org_study_id