Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer

Not Applicable

Not yet recruiting

• Conditions: Biliary Tract Cancer (BTC)
• Interventions: Drug: Yueju Pill + Standard Anti-tumor Therapy; Drug: Placebo + Standard anti-tumor therapy

• Registration Number: NCT07169916
• Lead Sponsor: Fudan University

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the impact of Yueju Pill on quality of life and treatment efficacy in patients with advanced biliary tract cancer (BTC) receiving standard therapy.

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the impact of Yueju Pill on quality of life and treatment efficacy in patients with unresectable advanced or metastatic biliary tract cancer (BTC) receiving guideline-based standard chemotherapy. The study will be conducted at Zhongshan Hospital Affiliated with Fudan University, Xuhui District Central Hospital of Shanghai, Minhang District Central Hospital of Shanghai, and Shanghai Geriatric Medical Center. Eligible patients will be randomized into two groups: Group A (Intervention): Standard chemotherapy + Yueju Pill (6-9 g per dose, twice daily, orally until disease progression or intolerable toxicity). Group B (Control): Standard chemotherapy + placebo (identical in appearance, packaging, dosage, and administration frequency to Yueju Pill).

Study Timeline

• Study First Submitted: 2025-08-21
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yueju group (Group A)	Yueju Pill + Standard Anti-tumor Therapy	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.
Placebo group (Group A)	Placebo + Standard anti-tumor therapy	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.

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life	18 week after treatment	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3) was used to assess changes (Δ) in quality-of-life scores from baseline to week 18 after treatment. Scores on the EORTC QLQ-C30 range from 0 to 100, with higher scores indicating better global health status/quality of life.

Secondary Outcome Measures

Name	Time	Method
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	1 year	The EORTC QLQ-C30 is a 30-item validated instrument assessing cancer-related quality of life across domains including physical, role, emotional, cognitive, and social functioning. Scores are transformed to a 0-100 scale. For functional and global health/QoL scales, higher scores indicate better quality of life. For symptom scales, higher scores indicate worse symptoms.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cholangiocarcinoma Module (EORTC QLQ-BIL21) Score	1 year	The EORTC QLQ-BIL21 is a 21-item validated module designed for patients with cholangiocarcinoma, assessing disease-related symptoms and impact. Scores are transformed to a 0-100 scale, with higher scores indicating worse symptoms.
Objective response rate (ORR)	1 year	defined according to RECIST v1.1 criteria, calculated as the proportion of patients achieving complete response (CR) or partial response (PR) among all evaluable patients (CR + PR).
Disease control rate (DCR)	1 year	defined according to RECIST v1.1 criteria, calculated as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) among all evaluable patients (CR + PR + SD).
Overall survival (OS)	1 year	defined as the time from randomization to death from any cause or to the date of the last follow-up, whichever occurs first.
Progression-free survival (PFS)	1 year	defined as the time from randomization to the first documented disease progression by imaging or death from any cause, whichever occurs first.
Patient Health Questionnaire-9 (PHQ-9) Score	1 year	The Patient Health Questionnaire-9 is a 9-item self-report instrument measuring depressive symptoms. Scores range from 0 (no depressive symptoms) to 27 (severe depression). Higher scores indicate worse depressive symptoms.
Generalized Anxiety Disorder-7 (GAD-7) Score	1 year	The Generalized Anxiety Disorder-7 is a 7-item self-report instrument measuring anxiety symptoms. Scores range from 0 (no anxiety symptoms) to 21 (severe anxiety). Higher scores indicate worse anxiety symptoms.
Change in Traditional Chinese Medicine (TCM) syndrome score	1 year	the study-specific TCM Syndrome Information Scale will be used to assess changes and improvement in patients' TCM syndrome characteristics before and after treatment. Scores range from 0 to 100, with higher scores indicating more severe TCM symptoms (worse outcome).

Trial Locations

Locations (1)

Zhongshan hospital Fudan University; 🇨🇳 Shanghai, Shanghai Municipality, China