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

NCT ID: NCT06234072

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2027-01-31

Brief Summary

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

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Astragalus + Gemcitabine

Intervention Type: DRUG

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 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).

Group Type: ACTIVE_COMPARATOR

Gemcitabine alone

Intervention Type: DRUG

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.

Interventions

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 effects. This synergistic approach holds potential for more effective and targeted therapeutic outcomes in pancreatic cancer patients.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xianbin Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shenzhen University General Hospital

Shenzhen, Guangdong, China

Countries

China

Central Contacts

Wei Zhang, PhD

Role: CONTACT

zhangwei9501@szu.edu.cn

+8618616835965

Mikiyas Amare Getu, PhD

Role: CONTACT

makmiky86@gmail.com

+8613028815957

Facility Contacts

Xianbin Zhang, PhD

Role: primary

xianbin.zhang@szu.edu.cn

+8613530765815

Other Identifiers

82104596

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GEN-SUR-001

Identifier Type: -

Identifier Source: org_study_id