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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen University General Hospital

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Astragalus + Gemcitabine
  • Gemcitabine alone

Treatment groups

120 Participants
are divided into 2 treatment groups