Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer

Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled in this study:

1. No gender restriction, age ≥18 years, and expected survival ≥3 months;
2. ECOG Performance Status (PS) of 0-1;
3. Child-Pugh class A;
4. Histologically confirmed diagnosis of advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, or gallbladder cancer;
5. At least one measurable lesion according to RECIST v1.1 criteria;
6. Planned to receive or currently receiving guideline-based, chemotherapy-centered systemic first- or second-line therapy;
7. Presence of mild to moderate anxiety or depressive symptoms (PHQ-9 or GAD-7 score of 5-14);
8. Adequate major organ function, including:

   1. Hematology (no blood transfusion or hematopoietic growth factors within 14 days): Hb ≥90 g/L, ANC ≥1.5×10⁹/L, PLT ≥90×10⁹/L, WBC ≥3.0×10⁹/L;
   2. Biochemistry: TBIL ≤1.5×ULN (≤2×ULN if liver metastases); ALT and AST ≤2.5×ULN (≤5×ULN if liver metastases); serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min; plasma albumin ≥30 g/L;
   3. Coagulation: INR and PT ≤1.5×ULN, APTT ≤1.5×ULN;
   4. Cardiac function: LVEF ≥50%, QTcF ≤450 msec (male) or ≤470 msec (female);
   5. Urine protein ≤2+, and if \>2+, 24-hour urine protein must be ≤1.0 g;
9. Not pregnant or breastfeeding, and subjects of childbearing potential must use effective contraception during treatment and for 3 months after treatment;
10. Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up.

Exclusion Criteria:

Subjects meeting any of the following criteria will not be eligible for this study:

1. Histological types of ampullary cancer, hepatocellular carcinoma, mixed-type liver cancer, or other malignancies not originating from bile duct cells;
2. History of or concurrent malignancy at other sites;
3. Severe anxiety or depression (PHQ-9 or GAD-7 score ≥15), currently receiving antidepressant or anti-anxiety medication, or history of substance abuse, alcoholism, or drug abuse;
4. Currently using other traditional Chinese medicine compound interventions;
5. Known allergy to monoclonal antibodies, anti-angiogenic drugs, gemcitabine, platinum drugs, or components of Chinese medicine;
6. Uncontrolled severe comorbidities, including:

   1. Congestive heart failure;
   2. Difficult-to-control hypertension;
   3. Angina or arrhythmias;
   4. Interstitial lung disease or active pulmonary tuberculosis;
   5. HBV DNA \>2000 copies/mL or HCV RNA \>1000 IU/mL after antiviral therapy;
   6. Known HIV positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
   7. Clinically significant gastroesophageal variceal bleeding within 3 months prior to enrollment, or known bleeding tendency;
   8. Coagulation abnormalities (PT \>14 sec), bleeding tendency, or currently receiving anticoagulant/thrombolytic therapy;
   9. Known or suspected active autoimmune disease, or requiring long-term systemic immunosuppressive therapy or corticosteroids;
7. Other factors that, in the investigator's judgment, may affect patient safety or trial compliance (e.g., severe laboratory abnormalities, psychiatric disorders, lack of family or social support).