Cholangiocarcinoma (Bile Duct Cancer) Clinical Trials

• (1) Subjects who meet all the following inclusion criteria will enter the pre-screening stage of this study and undergo the lesion puncture process:

‣ Voluntarily sign the informed consent form;

⁃ Aged ≥18 years and ≤75 years, regardless of gender;

⁃ Imaging assessment of unresectable advanced intrahepatic cholangiocarcinoma;

⁃ Have not received systemic or local treatment.

⁃ According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assess the lesions as measurable.

⁃ Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

⁃ Adequate fresh tumor tissue samples can be obtained for exome and transcriptome sequencing analysis;

⁃ Normal function of the main organs of the heart, liver and kidney:

• QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men, or ≤470 milliseconds for women;

∙ Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;

∙ 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;

∙ 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;

⁃ 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;

‣ Able to follow the study protocol and follow-up procedures.

• (2) Subjects who meet all the following inclusion criteria will enter the formal screening stage of this study and enter the study medication process:

⁃ Voluntary signing of the informed consent form;

⁃ Age ≥ 18 years and ≤ 75 years, regardless of gender;

⁃ Intrahepatic cholangiocarcinoma confirmed by pathology (histology or cytology);

⁃ Have not received any systemic treatment.

⁃ According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assessed the patients as having measurable lesions.

⁃ The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1;

⁃ The major organ functions of the heart, liver, and kidney were normal:

• QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men or ≤470 milliseconds for women;

∙ Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;

∙ 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;

∙ 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;

⁃ 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;

⁃ Able to follow the study protocol and follow-up process.