Cholangiocarcinoma (Bile Duct Cancer) Clinical Trials

• The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up.

• When signing the informed consent form, one must be at least 18 years old and no older than 75 years old, and there is no restriction on gender.

• Histologically confirmed cholangiocarcinoma or gallbladder cancer (excluding pancreatic cancer or ampullary cancer)

• Having undergone radical surgical treatment (R0 or R1 resection)

• The ECOG score is between 0 and 1

• The hematology and organ functions are adequate. Based on the following laboratory test results obtained within 14 days prior to the start of the treatment (unless otherwise specified)

• Blood routine test: (Within 14 days before screening, no blood transfusion, no use of G-CSF, and no use of drugs for correction) Hb ≥ 90 g/L; Neutrophils ≥ 1.5 × 10\^9/L; PLT ≥100×10\^9/L

• Biochemical test: (No albumin transfusion within 14 days)

• Appropriate liver function: ALT and AST ≤ 2.5 × ULN; serum bilirubin ≤ 2.0 × normal upper limit (ULN); these conditions do not apply to patients with confirmed Gilbert syndrome. Any clinically significant biliary obstruction should be relieved before enrollment. Albumin ≥ 2.8 g/dL. Appropriate renal function: creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) \> 50 mL/min (calculated using the standard Cockcroft-Gault formula)

⁃ Coagulation function: International Normalized Ratio (INR) ≤ 1.5

⁃ Fertile women: Agree to abstain from sexual intercourse (avoiding heterosexual intercourse) or use a contraceptive method with a failure rate of less than 1% during the treatment period and for at least 6 months after the last administration. If the female patient has menstruated, has not reached post-menopausal status (continuous absence of menstruation for ≥ 12 months, no other causes found apart from menopause), and has not undergone sterilization surgery (removal of ovaries and/or uterus), then it is considered that the patient is fertile. Examples of contraceptive methods with a failure rate of less than 1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormonal release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar days, ovulation period, symptom-based body temperature, or post-ovulation methods) and withdrawal from sexual intercourse are unacceptable contraceptive methods.

⁃ Male: Agree to abstinence (not engaging in heterosexual sexual intercourse) or use of contraceptive measures, agree not to donate sperm, defined as follows: When the female partner has reproductive capacity, the male patient must abstain from sexual activity during the treatment period and for 6 months after the last administration, or use condoms and other contraceptive methods to ensure a contraceptive failure rate of less than 1% per year. During the same period, the male patient must also agree not to donate sperm. When the female partner is pregnant, the male patient must abstain from sexual activity or use condoms for contraception during the treatment period and for 6 months after the last administration, to avoid any impact on the fetus. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar days, ovulation period, symptom-based body temperature or after ovulation methods) and withdrawal from sexual intercourse are unacceptable contraceptive methods.