Clinical trial · Interventional
Study of NAC of GA Therapy for Patients With BRPC
Phase II Study of Neoadjuvant Chemotherapy of Gemcitabine+Nab-paclitaxel Therapy for Patients With Borderline Resectable Pancreatic Cancer
NCT02926183CI-TRIAL-00040970unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GA regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine plus nab-paclitaxel
- description
- Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel: Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen.
- interventionNames
- Drug: Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel
Primary outcomes (1)
- measure
- Overall survival time from the first day of protocol therapy
- timeFrame
- Up to 60 months
Secondary outcomes (11)
- measure
- Recurrence free survival from the first day of protocol therapy
- timeFrame
- Up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous 2. Case with measurable lesion 3. First line treatment 4. PS (ECOG) 0-1 5. \>= 20 years old and \<80 years old 6. The following criteria must be satisfied in laboratory tests within 14 days of registration * WBC count\<=12,000/mm3 * Neutrophil count\>=1,500/mm3 * Hb \>= 9.0g/dl * Plt \>= 100,000/mm3 * T.Bil \<2.0mg/dl (\<3=.0mg/dl in biliary drainage case) * Serum Cr\<=upper limits of normal (ULN) * AST, ALT \<= 2.5xULN 7. Written informed consent to participate in this study Exclusion Criteria: 1. Severe drug hypersensitivity 2. Multiple primary cancers within 5 years 3. Severe infection 4. With grade2 or more severe peripheral neuropathy 5. Interstitial pneumonia or pulmonary fibrosis 6. With uncontrollable pleural effusion or ascites 7. With uncontrollable diabetes mellitus 8. With uncontrollable heart failure, angina, hypertension, arrhythmia 9. With severe neurological/psychological symptoms 10. With watery diarrhea 11. Pregnant or lactating women or women with unknown or suspected pregnancy 12. Inappropriate patients for entry on this study in the judgement of the investigator 13. Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)
References
Publications (1)
- DERIVEDOkada KI, Kimura K, Yamashita YI, Shibuya K, Matsumoto I, Satoi S, Yoshida K, Kodera Y, Akahori T, Hirono S, Eguchi H, Asakuma M, Tani M, Hatano E, Ikoma H, Ohira G, Hayashi H, Wan K, Shimokawa T, Kawai M, Yamaue H; NAC-GA investigators. Efficacy and safety of neoadjuvant nab-paclitaxel plus gemcitabine therapy in patients with borderline resectable pancreatic cancer: A multicenter single-arm phase II study (NAC-GA trial). Ann Gastroenterol Surg. 2023 Jul 8;7(6):997-1008. doi: 10.1002/ags3.12712. eCollection 2023 Nov. PMID 37927936