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

NCT06234072 | Not Yet Recruiting Phase 2

• 2 other identifiers: GEN-SUR-00182104596
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Surgical resection rate

  From first dose of study medication until approximately 1 year

• Percentage of patients with a 50% decrease in CA19-9

  From first dose of study medication until approximately 3 years

• Safety and Tolerance of Chemotherapeutic Drugs (CTCAE)

  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

• Overall Survival (OS)

  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

Study Arms (2)

Astragalus + Gemcitabine

EXPERIMENTAL

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.

Drug: Astragalus + Gemcitabine

Gemcitabine alone

ACTIVE COMPARATOR

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).

Drug: Gemcitabine alone

Interventions

Astragalus + Gemcitabine 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.

Astragalus + Gemcitabine

Gemcitabine alone 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.

Gemcitabine alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General Hospital

Shenzhen, Guangdong, 518055, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Wei Zhang, PhD

CONTACT

+8618616835965; zhangwei9501@szu.edu.cn

Mikiyas Amare Getu, PhD

CONTACT

+8613028815957; makmiky86@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

CN (1)