Biliary Tract Cancer (BTC)YJ-BTCNCT07169916
Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer
A study testing Yueju Pill + Standard Anti-tumor Therapy in people with Biliary Tract Cancer (BTC), run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- Yueju Pill + Standard Anti-tumor Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up.
Who cannot join
- 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;
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- 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;
- Known or suspected active autoimmune disease, or requiring long-term systemic immunosuppressive therapy or corticosteroids;
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Guoming Shi, Professor, +86 13916969578, shi.guoming@zs-hospital.sh.cn
Yixiao Zhang, M.D., zhang.yixiao.2022@outlook.com
About this study
Official title: Effect of Yueju Pill Combined With Standard Therapy on Quality of Life and Treatment Efficacy in Patients With Advanced Biliary Tract Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled 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.
Read the 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).
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- Yueju Pill + Standard Anti-tumor Therapy, Placebo + Standard anti-tumor therapy
- Keywords
- Biliary Tract Cancer, Yueju Pill, Quality of Life, Treatment Efficacy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yueju Pill + Standard Anti-tumor TherapyDrug
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 therapyDrug
Group B (Control): Standard therapy + placebo (identical in appearance, packaging, dosage, and administration frequency to Yueju Pill).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo + Standard anti-tumor therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 year
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.
Measured: 1 year
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).
Measured: 1 year
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).
Measured: 1 year
Overall survival (OS)
defined as the time from randomization to death from any cause or to the date of the last follow-up, whichever occurs first.
Measured: 1 year
Progression-free survival (PFS)
defined as the time from randomization to the first documented disease progression by imaging or death from any cause, whichever occurs first.
Measured: 1 year
Patient Health Questionnaire-9 (PHQ-9) Score
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.
Measured: 1 year
Generalized Anxiety Disorder-7 (GAD-7) Score
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.
Measured: 1 year
Change in Traditional Chinese Medicine (TCM) syndrome score
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shanghai Geriatric Medical Center, Minhang Central Hospital, Xuhui Central Hospital, Shanghai
- Responsible party
- Principal investigator, Jia Fan, Fudan University
- Investigators
- Jia Fan, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169916
- Sponsor's protocol ID
- YJ-BTC Trial
- Acronym
- YJ-BTC
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon completion of the study and following the publication of the paper, data supporting the findings of this study will be made available upon reasonable request from the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yueju Pill Combined With Standard Therapy on Quality of Life and Treatment Efficacy in Patients With Advanced Biliary Tract Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07169916
- Acronym / sponsor ID
- YJ-BTC / YJ-BTC Trial
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- Biliary Tract Cancer, Yueju Pill, Quality of Life, Treatment Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shanghai Geriatric Medical Center, Minhang Central Hospital, Xuhui Central Hospital, Shanghai
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Yueju group (Group A) | Experimental | Drug: Yueju Pill + Standard Anti-tumor TherapyIn 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 comparator | Drug: Placebo + Standard anti-tumor therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yueju Pill + Standard Anti-tumor TherapyGroup A (Intervention): Standard therapy + Yueju Pill (6-9 g per dose, twice daily, orally until disease progression or intolerable toxicity). | Drug | Yueju group (Group A) |
| Placebo + Standard anti-tumor therapyGroup B (Control): Standard therapy + placebo (identical in appearance, packaging, dosage, and administration frequency to Yueju Pill). | Drug | Placebo group (Group A) |
Primary outcome
Improvement in quality of life
Time frame: 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.
9 secondary outcomes
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Time frame: 1 year
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cholangiocarcinoma Module (EORTC QLQ-BIL21) Score
Time frame: 1 year
Objective response rate (ORR)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: 1 year
Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: 1 year
Change in Traditional Chinese Medicine (TCM) syndrome score
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No. Upon completion of the study and following the publication of the paper, data supporting the findings of this study will be made available upon reasonable request from the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jia Fan, Professor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yueju Pill + Standard Anti-tumor Therapy in people with Biliary Tract Cancer (BTC), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoming Shi, Professor (+86 13916969578, shi.guoming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in quality of life (time frame: 18 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.