Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma

Inclusion Criteria

• •1. Voluntarily sign the informed consent form;
• •2. Aged ≥18 years and ≤75 years, regardless of gender;
• •3. Imaging assessment of unresectable advanced intrahepatic cholangiocarcinoma;
• •4. Have not received systemic or local treatment.
• •5. According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assess the lesions as measurable.
• •6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• •7. Adequate fresh tumor tissue samples can be obtained for exome and transcriptome sequencing analysis;
• •8. Normal function of the main organs of the heart, liver and kidney:
• •1. QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men, or ≤470 milliseconds for women;
• •2. Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;
• •3. Hematological indicators: white blood cells ≥3.5×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HGB) ≥10 g/dL; platelet count (PLT) ≥80×109/L;
• •4. Biochemical indicators: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN is allowed for patients with liver metastasis and liver cancer); serum creatinine and urea nitrogen ≤ 1.5 times ULN;
• •9. Male and female patients of childbearing age with fertility agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of the trial drug; women of childbearing age include premenopausal women and women within 2 years after menopause;
• •10. Able to follow the study protocol and follow-up procedures.
• •1. Voluntary signing of the informed consent form;
• •2. Age ≥ 18 years and ≤ 75 years, regardless of gender;
• •3. Intrahepatic cholangiocarcinoma confirmed by pathology (histology or cytology);
• •4. Have not received any systemic treatment.
• •5. According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assessed the patients as having measurable lesions.
• •6. The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1;
• •7. The major organ functions of the heart, liver, and kidney were normal:
• •1. QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men or ≤470 milliseconds for women;
• •2. Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;
• •3. Hematological indicators: white blood cells ≥3.5×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HGB) ≥10 g/dL; platelet count (PLT) ≥80×109/L;
• •4. Biochemical indicators: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN is allowed for patients with liver metastasis and liver cancer); serum creatinine and urea nitrogen ≤ 1.5 times ULN;
• •8. Male patients with fertility and female patients of childbearing age agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration of the trial drug; women of childbearing age include premenopausal women and women within 2 years after menopause;
• •9. Able to follow the study protocol and follow-up process.