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Effect of Bupi Yichang Pill on Adverse Reactions in Patients with Hepato-Biliary-Pancreatic Cancers Receiving Radiotherapy: A Randomized Controlled Tria

Reactions in Patients with Hepato-Biliary-Pancreatic Cancers Receiving Radiotherapy: A Randomized Controlled Tria

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001647
Enrollment
Unknown
Registered
2025-09-01
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma,Gallbladder Cancer,Pancreatic Cancers

Interventions

Experimental group:Abdominal radiotherapy+Bupi Yichang Pills
Control group:Abdominal radiotherapy

Sponsors

The first affiliated hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: 18-75 years old 2: Meets the indication of radiotherapy 3: ECOG score 0-1 4: Liver function grade Child-Pugh 5-7 5: Blood, liver and kidney function meet the following conditions: a) Neutrophil count =1.5×109/L b) Platelet count =75×109/L c) hemoglobin concentration =90g/L d) serum albumin concentration =30g/L e) total bilirubin =50umol/L f) AST and ALT were less than 5 times the upper limit of normal, ALP less than 4 times the upper normal limit g) International normalized ratio =2.3 h) creatinine less than 1.5 times the upper normal limit 6: Sign informed consent for clinical trials

Exclusion criteria

Exclusion criteria: 1: with other malignancies or had other malignancies within 5 years prior to enrollment 2: A history of thoracic and abdominal radiation therapy 3: Pregnant or lactating women or subjects who planned to have a family within two years 4: Severe cardiac, renal, and other organ dysfunction, such as arrhythmia (requiring medication or pacemaker installation), uncontrollable hypertension, history of myocardial infarction within 6 months, QT interval extension exceeding 450ms, congestive heart failure>NYHA level 2 5: Unable to take oral medication 6: Informed consent or inability to cooperate may be affected by other serious medical conditions, such as alcoholism, drug abuse or mental illness

Design outcomes

Primary

MeasureTime frame
Gastrointestinal reactions;Bone marrow suppression;

Secondary

MeasureTime frame
Treatment completion rate;Immunomodulatory status; Quality of Life;

Countries

China

Contacts

Public ContactLiu Jiahui

The first affiliated hospital, Sun Yat-sen University

liujiah23@mail.sysu.edu.cn15989230877

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026