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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuncell-LC/Gemcitabine | Experimental | Patients will receive 6 cycles Gemcitabine (1000 mg/m2 on Days 1, 8, 15, 28-day a cycle) and Immuncell-LC 16 times during 60 weeks (4 treatments once a week, followed by 4 treatments every other week, then 4 treatments every 4 weeks, and finally 4 treatments every 8 weeks) |
|
| Gemcitabine | Active Comparator | Patients will receive 6 cycles Gemcitabine alone (1000 mg/m2 on Days 1, 8, 15, 28-day a cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immuncell-LC | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence 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 | Up to approximately 36 months after Last Patient In |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival is defined as the time from randomization to death due to any cause. | Up to approximately 36 months after Last Patient In |
| Recurrence free survival (RFS) by investigator |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Hyub Lee | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Daehak-ro, Jongno-gu | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37078953 | Derived | Choi JH, Nam GH, Hong JM, Cho IR, Paik WH, Ryu JK, Kim YT, Lee SH. Cytokine-Induced Killer Cell Immunotherapy Combined With Gemcitabine Reduces Systemic Metastasis in Pancreatic Cancer: An Analysis Using Preclinical Adjuvant Therapy-Mimicking Pancreatic Cancer Xenograft Model. Pancreas. 2022 Oct 1;51(9):1251-1257. doi: 10.1097/MPA.0000000000002176. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | IV |
|
Recurrence free survival is defined as the time from randomization to the date of the recurrence confirmed by investigator
| Up to approximately 36 months after Last Patient In |
| Carbohydrate antigen 19-9 level | Carbohydrate antigen 19-9 level | 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. | 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. | Up to approximately 36 months after Last Patient In |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |