Overview

Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

Status:
Recruiting

Trial end date:
2022-03-30

Target enrollment:
0

Participant gender:
All

Summary

This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sunshine Lake Pharma Co., Ltd.

Treatments:

Gemcitabine

Criteria

Inclusion Criteria:

18 ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group
(ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically
confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally
recurrent, or metastatic disease.

Exclusion Criteria:

adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy
and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the
first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g.,
serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound
evaluation of Left ventricular ejection fraction < 50%