Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreati… (NCT06234072) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients
China120 participantsStarted 2024-02
Plain-language summary
This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wo…
What they're measuring
1
Objective response rate (ORR)
Timeframe: From first dose of study medication until approximately 3 years