Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study on the Efficacy and Safety of Huaier Granules Combined With Capecitabine Versus Capecitabine Alone in the Treatment of Unresectable Pancreatic Cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 488
- 主要终点
- Overall survival
研究概览
简要总结
This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer.
详细描述
This study is a prospective, multicenter, randomized, open label, parallel controlled clinical study. It is expected to include approximately 488 patients diagnosed with unresectable pancreatic adenocarcinoma by tissue or cellular pathology who visited the selected research center from April 2024 to March 2026. The treatment regimen will be capecitabine monotherapy orally. Among them, the Huaier group uses "capecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, regardless of gender.
- •The patient has a clear evaluable lesion (RECIST 1.1) and is diagnosed with pancreatic adenocarcinoma through tissue or cellular pathology. Clinical evaluation suggests that radical surgical resection cannot be performed (due to jaundice and gastrointestinal obstruction caused by tumor compression, stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed).
- •Patients voluntarily give up conversion therapy, local radiation therapy, targeted immunity, and other programs.
- •The patient voluntarily choose chemotherapy, and the plan is to take capecitabine monotherapy orally.
- •ECOG score 0-3 points.
- •The patients voluntarily participate in and cooperates with all aspects of the research, including but not limited to cooperating with treatment and follow-up, cooperating with the researcher in data collection, not actively taking other treatments, and signing a written informed consent form.
排除标准
- •Known to be allergic to the components of Huaier granules or to avoid or use Huaier granules with caution (Huaier group).
- •Patients with difficulty swallowing, complete or incomplete gastrointestinal obstruction (excluding those who have undergone gastrointestinal stenting or diversion surgery due to tumor related gastrointestinal obstruction and have a normal diet, can be included in the study normally), active gastrointestinal bleeding, perforation, and other oral medication difficulties.
- •After actively reducing jaundice (including but not limited to bile duct/gallbladder puncture external drainage, nasobiliary duct external drainage, biliary stent internal drainage, biliary intestinal anastomosis internal drainage, etc.), the levels of aspartate aminotransferase, alanine aminotransferase, or total bilirubin are still 2.5 times higher than the upper limit of normal values.
- •History of merging with other malignant tumors.
- •Patients with concomitant myocardial infarction, cerebral infarction, and other thromboembolic diseases requiring surgical treatment.
- •Concomitant severe infection.
- •Child-Pugh C-grade liver function, renal function 2-5 grades (glomerular filtration rate<90ml/min).
- •Pregnant or lactating women or those planning to conceive.
- •The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect, chemotherapy or physical therapy in the past 4 weeks(including but not limited to compound cantharidin capsules, cinobufotalin capsules, Kangai injection, please refer to the drug instructions for details).
- •Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.
研究组 & 干预措施
Huaier treatment group
The subjects received a combination of Huaier granules and capecitabine regimen.The subject takes Huaier granules orally, 10g once, three times a day; take capecitabine 1250mg/m^2 orally , twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.
干预措施: Huaier Granule (Drug)
Control group
The subjects received the capecitabine monotherapy regimen. The subjects take capecitabine orally, 1250mg/m^2, twice a day (2500mg/m^2/d), day for 1-14 days, once every 3 weeks.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Overall survival
时间窗: Start of treatment until 2-year follow-up
It is defined as the time from the day of patient randomization to death due to any reason.
次要结局
- Objective response rate(Start of treatment until 2-year follow-up)
- Progression free survival(Start of treatment until 2-year follow-up)
- Conversion surgery rate(Start of treatment until 2-year follow-up)
- The incidence and severity of adverse events (AE) and severe adverse events (SAE)(Start of treatment until 2-year follow-up)
- The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)(Start of treatment until 2-year follow-up)
研究者
Zheng Wang
professor
Health Science Center of Xi'an Jiaotong University