Actively Recruiting
Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC
Led by Lei ZHAO · Updated on 2024-04-17
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of malignant intrahepatic cholangiocarcinoma
- Classified as stage Ib to IIIb according to UICC/AJCC TNM (8th edition, 2017)
- Age 18 years or older at consent
- Expected survival time longer than 3 months
- Both men and women are eligible
- Eastern Oncology Collaborative Group (ECOG) score of 0 or 1
- No severe complications like hypertension, coronary heart disease, mental illness, or severe allergies; not pregnant or lactating
- Adequate organ and blood function including: ANC 64; 1.5 x 10^9/L, platelet count 64; 75 x 10^9/L, hemoglobin 64; 90 g/L, serum total bilirubin 64; 1.5 times upper limit of normal, AST and ALT 64; 2.5 times upper limit of normal, albumin 64; 3 g/dL, creatinine 64; 1.5 times upper limit of normal
- Able to understand and sign informed consent; good compliance
- No prior local or systemic tumor treatment; if prior biliary tract cancer surgery, at least 2 years since radical resection before recurrence
- Use medically approved contraception during study and one month after; negative pregnancy test within 72 hours before enrollment; not lactating
You will not qualify if you...
- Prior treatment with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors, or other T cell receptor modulators
- Use of investigational drugs within 4 weeks before enrollment
- History of active autoimmune diseases or conditions requiring intervention
- Immunodeficiency including HIV infection, active hepatitis B or C, or co-infection
- Serious infection or unexplained fever over 38.5 6 C within 4 weeks before first treatment
- History of organ or stem cell transplantation
- Uncontrollable mental illness
- Serious or unstable diseases that may affect study participation (e.g., recent heart attack, unstable arrhythmia, congestive heart failure, poorly controlled diabetes, severe infections)
- Pregnancy or breastfeeding
- Other cancers within past 5 years except certain skin or in situ cancers
- Allergy or hypersensitivity to study drugs
- Current abuse of alcohol or illegal drugs
- Unable or unwilling to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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