Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
ConditionPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-80
SponsorGC Cell Corporation
About this trial
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.
Eligibility criteria
Qualifiers
Age >/=20 years old, </=80 years old.
Participants have undergone a radical full resection (R0) or boundary resection (R1) operation and has elapsed at least two weeks after the resection based on the baseline, up to 12 weeks.
Noncancerous ascites.
No evidence of distant metastasis (such as liver, peritoneum)
Disqualifiers
Received anticancer therapy including chemotherapy, biological therapy, immunotherapy, hormone therapy, radiation therapy, and other anti-cancer treatments. Note: Neo-adjuvant therapy for pancreatic cancer is allowed.
Measurable lesions identified in the pancreas after surgery.
Known history at the screening as defined below.
Confirmed cases of acquired immunodeficiency, which can be exacerbated by immunotherapy.
Trial design
Treatments tested in this trial
- Immuncell-LC
- Gemcitabine
Treatment groups
408 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov