A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

Inclusion Criteria:

1. Age ≥ 19 years

2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma orundifferentiated carcinoma of the pancreas.

3. Locally advanced or metastatic disease precluding curative surgical resection orpatients who have relapsed following previously resected pancreatic cancer.

4. Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days (and up toa maximum of 32 days) prior to commencing treatment.

5. Unidimensionally measurable disease (from CT scan) in accordance with the RECISTguidelines.

6. ECOG performance status 0, 1 or 2.

7. Adequate organ function as determined by the following laboratory values:

• Platelets ≥100 x 10^9 /L

• WBC ≥ 3 x 10^9 /L

• ANC ≥1.5 x 10^9 /L

• Serum total bilirubin ≤ 2.0 mg/dL

• CCr (Cockcroft & Gault) > 50 mL/min

8. Life expectancy ≥ 90 days

9. Fully informed written consent given.

Exclusion Criteria:

1. Brain metastasis or meningeal carcinomatosis.

2. Clinically significant serious disease or organ system disease not currentlycontrolled on present therapy.

3. Previous chemotherapy for locally advanced and metastatic disease. Previously adjuvantchemotherapy for resected pancreatic cancer will be permitted providing chemotherapywas completed more than 12 months previously.

4. Radiotherapy within the last 8 weeks prior to start of study treatment.

5. Concurrent malignancies or invasive cancers diagnosed within the past 5 years exceptfor adequately treated basal cell carcinoma of the skin, in situ carcinoma of theuterine cervix or resected pancreatic cancer.

6. Medication which might affect immunocompetence e.g. chronic treatment with long termsteroids or other immunosuppressant for an unrelated condition. Patients will beeligible if they have been receiving short term steroids for palliation of cancerrelated symptoms.

7. Administration of medicines from other clinical trials within 8 weeks fromregistration.

8. Pregnancy or breast feeding.

9. Uncontrolled angina pectoris.

10. Known malabsorption syndromes.

11. Patients with a known hypersensitivity to any of the investigational products orpatients with a dihydropyrimidine dehydrogenase (DPD) deficiency.

12. All men or women of reproductive potential, unless using at least two contraceptiveprecautions, one of which must be a condom.

13. Investigator's judgment against participation in the study