Overview

Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Status:
Enrolling by invitation
Trial end date:
2026-04-01
Target enrollment:
0
Participant gender:
All
Summary
Multiple centers, uncontrolled, open-label, non-randomized single-arm study
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chang Gung Memorial Hospital
China Medical University Hospital
Kaohsiung Medical University
National Cheng-Kung University Hospital
National Taiwan University Hospital
Treatments:
Gemcitabine
Leucovorin
Criteria
Inclusion Criteria:

1. Patients must have cyto-/histologically confirmed, recurrent or metastatic
adenocarcinoma of the pancreas.

2. Patients have disease measurable or evaluable on x-ray, computed tomography scan, or
physical examination.

3. Patients have no history of prior chemotherapy for metastatic pancreatic cancer.
Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which
was completed at least 6 months before recurrence are eligible.

4. Patients with prior radiotherapy are eligible if the irradiated area does not involve
the only lesion of measurable / evaluable disease.

5. Baseline ECOG performance status is 2.

6. Patients have life expectancy of at least 12 weeks.

7. Patients have age 70 years.

8. Patients have adequate organ function.

9. Patients with biliary obstruction which is adequate drained before enrollment are
eligible.

10. Patients agree to have an indwelling venous catheter implanted.

11. Women or men of reproductive potential should agree to use an effective contraceptive
method.

12. All patients must be informed of the investigational nature of this study and must
sign written informed consents.

Exclusion Criteria:

1. Patients who have major abdominal surgery, radiotherapy or other investigating agents
within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony
metastasis will be eligible if the irradiated area does not involve the only lesion of
measurable / evaluable disease.

2. Patients with metastatic lesion in central nervous system.

3. Patients with active infection.

4. Patients with active cardiopulmonary disease or history of ischemic heart disease.

5. Patients who have peripheral neuropathy > grade I of any etiology.

6. Patients who have serious concomitant systemic disorders incompatible with the study,
i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the
liver, and the rest will be at the discretion of in-charged investigator.

7. Patients who have other prior or concurrent malignancy except for adequately treated
in situ carcinoma of cervix or adequately.