Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
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.
| Condition(s) | Pancreatic Ductal Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 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) * No evidence of distant metastasis in other distant abdominal or extra-abdominal organs * Scheduled to be given gemcitabine alone as postoperative adjuvant chemotherapy 3. Eastern Cooperative Oncology Group-performance status (ECOG-PS) 0 - 2 4. Life expectancy is at least 12 weeks. 5. Adequate organ and marrow function at the screening |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Lead sponsor | GC Cell Corporation |
| Locations | Seoul, Daehak-ro, Jongno-gu, South Korea |
| Start date | 2021-09-07 |
| NCT ID | NCT04969731 |
| Official listing | https://clinicaltrials.gov/study/NCT04969731 |