Comparison of Neoadjuvant Treatment for Pancreatic Cancer: Astragalus Combined With Gemcitabine Versus Gemcitabine Alone - A Single-Center, Randomized, Double-Blind Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.
详细描述
Astragalus is a commonly used traditional Chinese medicine in China, which has been widely applied to enhance the immunomodulatory function of the body and suppress the growth of tumors. It was often combined with other herbs to strengthen the body against disease. The effects and mechanisms of Astragalus and Shenqi Fuzheng Injection (the main ingredients are Codonopsis and Astragalus) in the treatment of digestive tract diseases were studied. Investigators found that Astragalus can not only inhibit the growth of pancreatic tumors, but also down regulate the ability of CAFs to secrete βig-h3, thereby inducing CD8+T proliferation and inhibiting the polarization of macrophages into M2 macrophages, thereby enhancing the response of pancreatic tumors to gemcitabine and other treatment options.
Thus, the objective of this study is to compare the impact of combining Astragalus with Gemcitabine versus Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.
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
- Double (Participant, Outcomes Assessor)
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
- •Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;
- •Is 18 years of age or older;
- •ECOG performance status 0 to 2;
- •Patient organ function tests must meet the following laboratory parameters:
- •Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.
- •Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be ≤ 5 times ULN),
- •Neutrophils 1,500/Ul,
- •hemoglobin > 8.0 gm/dL,
- •Platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L),
- •serum creatinine < 2.0 mg/dL,
- •Expected postoperative survival ≥ 3 months;
- •Ability to comply with the study visit plan and other protocol requirements;
- •Voluntary participation and signing of informed consent.
- •Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •CNS damage or soft meningeal disease;
- •Metastasis to distant sites;
- •Other serious diseases or conditions, including congestive heart failure (New York Heart Association class III or IV), unstable angina pectoris, infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, and substance abuse;
- •Known hypersensitivity to Astragalus or gemcitabine;
- •Pregnant or lactating women. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the treatment period of this trial and for 12 weeks after the last dose of study drug. Sexually active, fertile men who are not using effective contraception themselves if their partner is a woman of childbearing potential;
- •Known neuroendocrine tumor of the pancreas;
- •Receiving a concomitant treatment with drugs interacting with gemcitabine;
- •Past or concurrent cancers with primary foci or histology completely different from pancreatic cancer, except for cervical cancer in situ, previously treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer cured >5 years prior to enrollment is allowed;
- •Inability to swallow herbal medicines or untreated malabsorption syndrome and unwillingness to take herbal medicines.
- •Patients with poor compliance
研究组 & 干预措施
Astragalus + Gemcitabine
Participants will receive Astragalus in combination with Gemcitabine by intravenous infusion (IV).
Participants will receive IV infusion of 20ml of Astragalus injection (the content of Astragalus crude drug is 2g/ml plus 250ml of normal saline 1 day before chemotherapy, once a day for 21 consecutive days constitute a course of treatment a total of 4 courses of treatment.
Gemcitabine is one of the main chemotherapy drugs used to treat pancreatic cancer.
干预措施: Astragalus + Gemcitabine (Drug)
Gemcitabine alone
Participants will receive Neoadjuvant Chemotherapy of Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).
干预措施: Gemcitabine alone (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: From first dose of study medication until approximately 3 years
Objective response rate (ORR) measures the overall treatment response by assessing the percentage of patients with complete or partial tumor shrinkage after treatment.
次要结局
- Percentage of patients with a 50% decrease in CA19-9(From first dose of study medication until approximately 3 years)
- Safety and Tolerance of Chemotherapeutic Drugs (CTCAE)(From first dose of study medication until 30 days after the end of treatment, up to approximately 3 years)
- Progression-free survival(PFS)(From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, up to approximately 3 years)
- Overall Survival (OS)(From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, up to approximately 3 years)
- Surgical resection rate(From first dose of study medication until approximately 1 year)
- Proportion of participants with R0 resection(From first dose of study medication until approximately 1 year)
研究者
Xianbin Zhang
Principal Investigator
Shenzhen University General Hospital