Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer

Recruiting Phase 3 Interventional Study
Pancreatic Ductal Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
408 (estimated)
Sponsor
GC Cell Corporation · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age \>/=20 years old, \</=80 years old. 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that fulfill the following requirements: * Participants have undergone a radical full resection (R0) or boundary resection (R1) operation and has elapsed …
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