Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer
NCT ID: NCT07169916
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
210 participants
INTERVENTIONAL
2025-09-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Yueju group (Group A)
In addition to guideline-based standard therapy, patients will receive Yueju Pill according to the instructions, 6-9 g per dose, twice daily, orally, continued until tumor progression or until the patient is unable to continue treatment for other reasons.
Yueju Pill + Standard Anti-tumor Therapy
Group A (Intervention): Standard therapy + Yueju Pill (6-9 g per dose, twice daily, orally until disease progression or intolerable toxicity).
Placebo group (Group A)
Patients will receive guideline-based standard therapy combined with a placebo. The placebo is matched to Yueju Pill in appearance, smell, packaging, administration method, dosage, and treatment schedule.
Placebo + Standard anti-tumor therapy
Group B (Control): Standard therapy + placebo (identical in appearance, packaging, dosage, and administration frequency to Yueju Pill).
Interventions
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Yueju Pill + Standard Anti-tumor Therapy
Group A (Intervention): Standard therapy + Yueju Pill (6-9 g per dose, twice daily, orally until disease progression or intolerable toxicity).
Placebo + Standard anti-tumor therapy
Group B (Control): Standard therapy + placebo (identical in appearance, packaging, dosage, and administration frequency to Yueju Pill).
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Shanghai Geriatric Medical Center
OTHER
Minhang Central Hospital
UNKNOWN
Xuhui Central Hospital, Shanghai
OTHER
Fudan University
OTHER
Responsible Party
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Jia Fan
Professor
Principal Investigators
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Jia Fan, Professor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YJ-BTC Trial
Identifier Type: -
Identifier Source: org_study_id
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