This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Participants will receive Astragalus combined with Gemcitabine. Astragalus, a traditional Chinese medicine, exhibits promising potential in cancer treatment. Studies suggest its role in regulating immune responses, suppressing tumors, and improving overall treatment outcomes in cancer patients. Astragalus combined with chemotherapeutic drug such as Gemcitabine is a popular complementary and alternative therapy used for cancer patients because it can increase therapeutic effects and decrease side effects. This synergistic approach holds potential for more effective and targeted therapeutic outcomes in pancreatic cancer patients.
Gemcitabine is a potent chemotherapy drug widely employed in treating various cancers, including pancreatic cancer. As a nucleoside analog, it disrupts DNA synthesis, impeding cancer cell proliferation. Gemcitabine is administered intravenously and has shown efficacy in alleviating symptoms, improving survival rates, and enhancing the quality of life for patients undergoing cancer treatment.
Shenzhen University General Hospital
Shenzhen, Guangdong, China
Objective response rate (ORR)
Objective response rate (ORR) measures the overall treatment response by assessing the percentage of patients with complete or partial tumor shrinkage after treatment.
Time frame: From first dose of study medication until approximately 3 years
Surgical resection rate
Surgical resection rate refers to the percentage of patients who undergo surgical removal (resection) of a tumor or diseased tissue as part of their medical treatment.
Time frame: From first dose of study medication until approximately 1 year
Percentage of patients with a 50% decrease in CA19-9
Percentage of patients with a 50% decrease in CA19-9 measures the proportion of individuals whose CA19-9 tumor marker levels have reduced by at least 50%, indicating a potential positive response to treatment
Time frame: From first dose of study medication until approximately 3 years
Safety and Tolerance of Chemotherapeutic Drugs (CTCAE)
Safety and Tolerance of Chemotherapeutic Drugs refers to the assessment of adverse events and side effects associated with chemotherapy, using the Common Terminology Criteria for Adverse Events (CTCAE) scale, which evaluates the safety profile and tolerability of chemotherapy in patients.
Time frame: 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.
Time frame: 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
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Overall Survival (OS)
OS will be calculated as date of death minus date of first dose of study medication plus 1. In the absence of death confirmation, OS will be censored at the date of last study follow-up. Analysis will be performed by Kaplan-Meier method.
Time frame: 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
Proportion of participants with R0 resection
R0 resection rate signifies the percentage of surgical procedures in which the entire tumor is successfully removed with no residual cancerous tissue remaining (complete microscopic tumor removal).
Time frame: From first dose of study medication until approximately 1 year