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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma;
- According to the UICC/AJCC TNM staging system (8th edition, 2017), resectablesubjects were classified as Ib-IIIb stages;
- aged ≥ 18 years at the time of signing the Informed consent form (ICF);
- Expected survival time>3 months;
- Both men and women are eligible;
- The patient's Eastern Oncology Collaborative Group (ECOG) physical condition scoreis 0 or 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;
- The organ and blood system functions of the subjects meet the followingrequirements:
- 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
- The subjects can understand and sign the informed consent form to participate inthe experimental study; Good compliance.
- 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;
- 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:
- 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);
- Use any other investigational drugs within 4 weeks prior to enrollment;
- 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;
- 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;
- 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;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation;
- Suffering from uncontrollable mental illness;
- 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);
- Pregnancy (positive pregnancy test) or lactation period;
- Other cancers that have occurred in the past (within the past 5 years) orsimultaneously, excluding non melanoma skin cancer and in situ cancer;
- History of allergy or hypersensitivity to any investigational drug;
- Currently abusing alcohol or illegal drugs;
- 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
ChinaActive - Recruiting
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