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New treatment option for Intrahepatic Cholangiocarcinoma
Official title Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC
ClinicalTrials.gov ID: NCT06296563
What this study is testing
What is Adebrelimab?
Adebrelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma;
- 2\. According to the UICC/AJCC TNM staging system (8th edition, 2017), resectable people 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;
You likely can't join if
- 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...
- 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...
- 4\. Congenital or acquired immunodeficiency, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml)...
- 5\. Serious infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first...
- 6\. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
See the full eligibility criteria
- 1\. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma;
- 2\. According to the UICC/AJCC TNM staging system (8th edition, 2017), resectable people 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 people meet the following requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10 \^ 9/L;
- Platelet count ≥ 75 × 10 \^ 9/L;
- Hemoglobin ≥ 90 g/L;
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN;
- Albumin ≥ 3g/dL
- Creatinine ≤ 1.5 x ULN
- 9\. The people 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...
- 11\. people 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.