A phase 1 study of combination therapy with gemcitabine and candesartan in patients with pancreatic cancer

A phase 1 study of combination therapy with gemcitabine and candesartan in patients with pancreatic cancer - GECA-1 study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002152

Enrollment

Registered

2009-07-01

Start date

2009-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Combination therapy with gemcitabine and candesartan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with non-resectable or post-operative recurrent pancreatic cancer 2) Patients with pathologically proven or graphically confirmed pancreatic cancer 3) Patients with no prior therapy except surgery 4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 5) Patients of age >= 20 years 6) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= the upper limit of normal, and potassium <= the upper limit of normal 7) Written informed consent is required from all patients.

Exclusion criteria

Exclusion criteria: 1) Patients with systolic blood pressure < 100mmHg 2) Patients with an active concomitant infection 3) Patients with digestive ulcer or gastrointestinal bleeding 4) Patients with severe heart or renal disease 5) Patients with an active pulmonary fibrosis or interstitial pneumonia 6) Patients with a previous history of a severe drug hypersensitivity 7) Patients with an active concomitant malignancy 8) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 9) Patients with hypertension 10) Patients who received ACE or ARB 11) Patients with uncontrollable massive pleural effusion or massive ascites 12) Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicity, maximum tolerated dose, recommended dose	—

Secondary

Measure	Time frame
Adverse effects, response rate, disease control rate, progression free survival, overall survival	—

Countries

Japan

Contacts

Public ContactYousuke Nakai

University of Tokyo Department of Gastroenterology

ynakai-tky@umin.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026