PURPOSE: This phase III clinical trial evaluates the efficacy and safety of adjuvant Immuncell-LC therapy combined with gemcitabine versus adjuvant gemcitabine single therapy after R0 or R1 resection in patients with pancreatic ductal adenocarcinoma.
Open-label, Randomized, Multi-center, Parallel, Phase III Clinical Trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
408
IV
IV
Seoul National University Hospital
Seoul, Daehak-ro, Jongno-gu, South Korea
RECRUITINGRecurrence free survival (RFS) by independent review
Recurrence free survival is defined as the time from randomization to the date of the recurrence confirmed by independent reviewer
Time frame: Up to approximately 36 months after Last Patient In
Overall survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 36 months after Last Patient In
Recurrence free survival (RFS) by investigator
Recurrence free survival is defined as the time from randomization to the date of the recurrence confirmed by investigator
Time frame: Up to approximately 36 months after Last Patient In
Carbohydrate antigen 19-9 level
Carbohydrate antigen 19-9 level
Time frame: Up to approximately 36 months after Last Patient In
Quality of Life (QoL) EORTC QLQ-C30
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Time frame: Up to approximately 36 months after Last Patient In
Quality of Life (QoL) EORTC QLQ-PAN26
The module comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes). The answers range is the following: not at all - 1 point, a little - 2 points, quite a bit - 3 points, very much - 4 points. Minimum score is 26, maximum is 106. The higher total score represents the worse quality of life.
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Time frame: Up to approximately 36 months after Last Patient In