Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer (NCT07169916) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer
China210 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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;