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To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.
Full description
This study is designed as a phase III, prospective, randomized, open-label, multicenter clinical trial comparing GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in treating locally advanced and metastatic pancreatic cancer patients. Patients will be treated until disease progression and will be subject to follow-up until death.
Patients will be randomized equally between the two arms:
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Inclusion criteria
Age ≥ 19 years
Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas.
Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer.
Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days (and up to a maximum of 32 days) prior to commencing treatment.
Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines.
ECOG performance status 0, 1 or 2.
Adequate organ function as determined by the following laboratory values:
Life expectancy ≥ 90 days
Fully informed written consent given.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
148 participants in 2 patient groups
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Central trial contact
Hanna Park; Yoon Jin Lee
Data sourced from clinicaltrials.gov
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