Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer
ConditionBiliary Tract Cancer (BTC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Yueju Pill + Standard Anti-tumor Therapy
- Placebo + Standard anti-tumor therapy
Treatment groups
210 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fudan University
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Shanghai Geriatric Medical Center
Collaborator
Minhang Central Hospital
Collaborator
Xuhui Central Hospital, Shanghai
Collaborator
Source ClinicalTrials.gov