RecruitingPhase 3NCT04969731

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

An Open-label, Randomized, Multi-center, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Immuncell-LC Therapy Combined With Gemcitabine Versus Adjuvant Gemcitabine Single Therapy After Resection in Patients With Pancreatic Ductal Adenocarcinoma


Sponsor

GC Cell Corporation

Enrollment

408 participants

Start Date

Sep 7, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding Immuncell-LC (an immune cell therapy made from the patient's own activated T-cells) to the standard chemotherapy drug gemcitabine improves survival after surgery for pancreatic cancer. **You may be eligible if...** - You are between 20 and 80 years old - You have been diagnosed with pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) and have had it fully or mostly removed by surgery (R0 or R1 resection) at least 2 weeks ago but no more than 12 weeks ago - There is no evidence the cancer has spread to other organs - You are scheduled to receive gemcitabine chemotherapy after surgery - Your general health is adequate (ECOG 0–2) and major organs are functioning well **You may NOT be eligible if...** - You have evidence of distant spread (metastases) - You had a non-curative surgery - Your organ function is too poor - You have had prior chemotherapy or radiation for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImmuncell-LC

IV

DRUGGemcitabine

IV


Locations(1)

Seoul National University Hospital

Seoul, Daehak-ro, Jongno-gu, South Korea

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NCT04969731


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