Clinical Efficacy of QYHJ and Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer
Status:
Recruiting
Trial end date:
2025-12-30
Target enrollment:
Participant gender:
Summary
Our study is a prospective, multicenter, randomized controlled clinical study included
patients with stage IV pancreatic ductal adenocarcinoma receiving gemcitabine-based
first-line combination therapy according to the 2022 NCCN guidelines and with an estimated
survival of > 3 months. According to reports and previous research results, we plan to
include 306 subjects, and the subjects will divide into experimental group and the control
group by a ratio of 1:1. All patients in the treatment group will receive QingyiHuaji
optimized formula and standard treatment, and patients in the control group will receive
placebo combined with standard treatment. Overall survival (OS) is defined as the primary
endpoint, and progression-free survival (DFS), quality of life of cancer patients, and relief
rate of TCM symptoms are considered as the secondary endpoint to observe the clinical
efficacy of Qingyihuaji optimized formula combined with standard chemotherapy for stage IV
pancreatic ductal adenocarcinoma. It will provide high-level evidence-based medical basis for
the clinical effect of Qingyihuayi optimization prescription on pancreatic cancer with
damp-heat accumulation syndrome. The hypothesis of this study is that the combination of
Qingyihuaji optimized prescription with standard chemotherapy has the advantage of
significantly prolonging the overall survival time, and is feasible and safe for the subjects
diagnosed with stage IV pancreatic ductal adenocarcinoma by cytology or histology. The study
lasted for 32 months, from 2023 April to December 2025.