This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.
Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;
Is 18 years of age or older;
ECOG performance status 0 to 2;
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.
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;
Parallel
Astragalus + Gemcitabine
DrugParticipants 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 alone
DrugGemcitabine 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.
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.
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.
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
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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
