Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer

NCT07169916 | Not Yet Recruiting

• 1 other identifier: YJ-BTC Trial
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer (BTC)

Keywords

Biliary Tract Cancer; Yueju Pill; Quality of Life; Treatment Efficacy

Outcome Measures

Primary Outcomes (1)

• Improvement in quality of life

  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.

  18 week after treatment

Secondary Outcomes (9)

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score

  1 year

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cholangiocarcinoma Module (EORTC QLQ-BIL21) Score

  1 year

• Objective response rate (ORR)

  1 year

• Disease control rate (DCR)

  1 year

• Overall survival (OS)

  1 year

Other Outcomes (8)

• Incidence of treatment-related adverse events (AE/SAE)

  1 year

• Serum Cortisol Concentration

  Baseline and at the end of each treatment cycle (each cycle is 21 days) during the treatment period.

• Serum Amino Acid Concentrations

  Baseline and at the end of each treatment cycle (each cycle is 21 days) during the treatment period.

Study Arms (2)

Yueju group (Group A)

EXPERIMENTAL

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.

Drug: Yueju Pill + Standard Anti-tumor Therapy

Placebo group (Group A)

PLACEBO COMPARATOR

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.

Drug: Placebo + Standard anti-tumor therapy

Interventions

Yueju Pill + Standard Anti-tumor Therapy DRUG

Group A (Intervention): Standard therapy + Yueju Pill (6-9 g per dose, twice daily, orally until disease progression or intolerable toxicity).

Yueju group (Group A)

Placebo + Standard anti-tumor therapy DRUG

Group B (Control): Standard therapy + placebo (identical in appearance, packaging, dosage, and administration frequency to Yueju Pill).

Placebo group (Group A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be enrolled in this study:
• No gender restriction, age ≥18 years, and expected survival ≥3 months;
• ECOG Performance Status (PS) of 0-1;
• Child-Pugh class A;
• Histologically confirmed diagnosis of advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, or gallbladder cancer;
• At least one measurable lesion according to RECIST v1.1 criteria;
• Planned to receive or currently receiving guideline-based, chemotherapy-centered systemic first- or second-line therapy;
• Presence of mild to moderate anxiety or depressive symptoms (PHQ-9 or GAD-7 score of 5-14);
• Adequate major organ function, including:
• 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;
• 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;
• Coagulation: INR and PT ≤1.5×ULN, APTT ≤1.5×ULN;
• Cardiac function: LVEF ≥50%, QTcF ≤450 msec (male) or ≤470 msec (female);
• Urine protein ≤2+, and if \>2+, 24-hour urine protein must be ≤1.0 g;
• Not pregnant or breastfeeding, and subjects of childbearing potential must use effective contraception during treatment and for 3 months after treatment;

You may not qualify if:

• Subjects meeting any of the following criteria will not be eligible for this study:
• Histological types of ampullary cancer, hepatocellular carcinoma, mixed-type liver cancer, or other malignancies not originating from bile duct cells;
• History of or concurrent malignancy at other sites;
• 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;
• Currently using other traditional Chinese medicine compound interventions;
• Known allergy to monoclonal antibodies, anti-angiogenic drugs, gemcitabine, platinum drugs, or components of Chinese medicine;
• Uncontrolled severe comorbidities, including:
• Congestive heart failure;
• Difficult-to-control hypertension;
• Angina or arrhythmias;
• Interstitial lung disease or active pulmonary tuberculosis;
• HBV DNA \>2000 copies/mL or HCV RNA \>1000 IU/mL after antiviral therapy;
• Known HIV positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
• Clinically significant gastroesophageal variceal bleeding within 3 months prior to enrollment, or known bleeding tendency;
• Coagulation abnormalities (PT \>14 sec), bleeding tendency, or currently receiving anticoagulant/thrombolytic therapy;

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Zhongshan Hospital: collaborator
• Shanghai Geriatric Medical Center: collaborator
• Minhang Central Hospital: collaborator
• Xuhui Central Hospital, Shanghai: collaborator

Study Sites (1)

Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Jia Fan, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoming Shi, Professor

CONTACT

+86 13916969578; shi.guoming@zs-hospital.sh.cn

Yixiao Zhang, M.D.

CONTACT

+86 13661702682; zhang.yixiao.2022@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind. Subjects, investigators, site staff, CRCs, and assessors will remain blinded to the intervention (Yueju Pill or placebo). Study drug and placebo are identical in appearance, packaging, color, odor, specifications, and labeling. Standard-of-care treatment is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)