Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients

Официальное название

Comparison of Neoadjuvant Treatment for Pancreatic Cancer: Astragalus Combined With Gemcitabine Versus Gemcitabine Alone - A Single-Center, Randomized, Double-Blind Study

Обзор

This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.

Подробное описание

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.

Вмешательства

• Препарат Astragalus + Gemcitabine
  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
• Препарат Gemcitabine alone
  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.

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: From first dose of study medication until approximately 3 years]

Вторичные конечные точки (6)

• Surgical resection rate [Срок оценки: From first dose of study medication until approximately 1 year]
• Percentage of patients with a 50% decrease in CA19-9 [Срок оценки: From first dose of study medication until approximately 3 years]
• Safety and Tolerance of Chemotherapeutic Drugs (CTCAE) [Срок оценки: From first dose of study medication until 30 days after the end of treatment, up to approximately 3 years]
• Progression-free survival(PFS) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From first dose of study medication until approximately 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shenzhen University General Hospital — Шэньчжэнь

Идентификаторы

NCT: NCT06234072 · GEN-SUR-001 · 82104596

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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