Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 642
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer
详细描述
The study is a multicenter, prospective clinical study, expected to include subjects who visited the selected research center from April 2024 to March 2026, underwent radical tumor resection surgery, and were pathologically diagnosed with pancreatic adenocarcinoma. The subjects are divided into two groups. One group is the standard chemotherapy group, with a planned inclusion of no less than 428 subjects. The chemotherapy will be treated using the Class 1A chemotherapy regimen recommended by the 2022 version of the CSCO guidelines; One group is the Huaier treatment group, with a planned inclusion of no less than 214 subjects. All subjects voluntarily give up the postoperative adjuvant treatment recommended by the guidelines and only choose Huaier granules for postoperative adjuvant treatment. A total of no less than 642 subjects are planned to be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 80 years old, regardless of gender;
- •Pancreatic cancer was diagnosed by histopathology after radical surgery within 12 weeks before enrollment;
- •Did not receive neoadjuvant therapy before surgery and did not receive any adjuvant therapy after surgery;
- •ECOG score 0-3 points;
- •Those who choose to use standard chemotherapy independently based on their own situation, or choose Huaier granules for subsequent treatment, voluntarily participate in and cooperate with various research work, including but not limited to cooperating with treatment and follow-up, cooperating with researchers for data collection, and not actively taking other treatments.
- •The subjects voluntarily signed a written informed consent form before participating in this study.
排除标准
- •Known to be allergic to the components of Huaier granules or to avoid or use Huai er granules with caution (Huaier group);
- •Difficulties in taking oral medication due to active gastrointestinal bleeding, perforation, gastric paralysis, etc;
- •Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.
- •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).
研究组 & 干预措施
Huaier treatment group
The subjects take Huaier granules orally and start taking them within 15-30 days after surgery until the end of the study, intolerable toxicity occurs, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit.
干预措施: Huaier granule (Drug)
Standard chemotherapy group
Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment)
- Gemcitabine combine with capecitabine
- mFOLFIRINOX solution
- Gemcitabine monotherapy
- Tegafur，gimeracil and oteracil potassium capsules monotherapy
干预措施: chemotherapy drugs (Drug)
结局指标
主要结局
Disease-free survival
时间窗: Start of treatment until 2-year follow-up
It is defined as the time from the first day after radical resection of pancreatic cancer to recurrence or all-cause death of pancreatic cancer.
次要结局
- Overall survival(Start of treatment until 2-year follow-up)
- Progression-free survival(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