Comparing Astragalus Plus Gemcitabine To Gemcitabine Alone As Neoadjuvant Treatment For Pancreatic Cancer Patients

Study Overview

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

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.

Pancreatic Cancer

DRUG: Astragalus + Gemcitabine
DRUG: Gemcitabine alone

GEN-SUR-001
82104596 (OTHER_GRANT Identifier) (OTHER_GRANT: National Natural Science Foundation of China)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-01-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-31
First Submitted that Met QC Criteria 2024-01-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-02
First Posted (ACTUAL) 2024-01-31	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 befo	DRUG: 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 overal
ACTIVE_COMPARATOR: 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 administ	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 sh

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 befo

DRUG: 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 overal

ACTIVE_COMPARATOR: 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 administ

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 sh

Primary Outcome Measures	Measure Description	Time Frame
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.	From first dose of study medication until approximately 3 years

Secondary Outcome Measures	Measure Description	Time Frame
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.	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	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.	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.	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)	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.	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).	From first dose of study medication until approximately 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wei Zhang, PhD

Phone Number: +8618616835965

Email: zhangwei9501@szu.edu.cn

Study Contact Backup

Name: Mikiyas Amare Getu, PhD

Phone Number: +8613028815957

Email: makmiky86@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.
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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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