Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Placebo + Standard anti-tumor therapy

    Drug

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

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Yueju group (Group A)Experimental treatment 1 intervention
Group B: Placebo group (Group A)Placebo comparator 1 intervention

Trial outcomes

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.

Time frame
18 week after treatment

Secondary outcomes

1

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

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.

Time frame
1 year
2

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

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.

Time frame
1 year
3

Objective response rate (ORR)

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).

Time frame
1 year
4

Disease control rate (DCR)

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).

Time frame
1 year

Other outcomes

1

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

all adverse events will be recorded and graded according to the NCI CTCAE v5.0 criteria, including but not limited to nausea, vomiting, and hepatic function abnormalities, with frequency and severity summarized.

Time frame
1 year
2

Serum Cortisol Concentration

Cortisol levels in peripheral blood will be measured as a biomarker of stress response. Concentrations will be quantified using immunoassay.Unit of Measure: μg/dL

Time frame
Baseline and at the end of each treatment cycle (each cycle is 21 days) during the treatment period.
3

Serum Amino Acid Concentrations

Peripheral blood levels of selected amino acids (e.g., tryptophan, glutamine, arginine) will be measured as metabolic biomarkers using liquid chromatography-mass spectrometry (LC-MS).Unit of Measure: μmol/L

Time frame
Baseline and at the end of each treatment cycle (each cycle is 21 days) during the treatment period.
4

Composite Distribution of Peripheral Immune Cell Subsets

The proportion of major immune cell subsets in peripheral blood will be assessed by flow cytometry. The composite outcome includes: T lymphocytes (CD3+) CD4+ T cells (CD3+CD4+) CD8+ T cells (CD3+CD8+) B lymphocytes (CD19+ or CD20+) Natural killer (NK) cells (CD3-CD56+ and/or CD16+CD56+) Each component will be reported as the percentage of peripheral blood mononuclear cells (PBMCs). The composite outcome is defined as the 5-component vector of these percentages, with summary statistics (mean, SD, median, IQR) and changes from baseline presented for each subset.Unit of Measure: % of PBMCs

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: