Clinical trial · Interventional
Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
NCT03779464CI-TRIAL-00039368unknownPhase 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)
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gemcitabine | — | UNRESOLVED | — |
| Nab-paclitaxel | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| S1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S1 or Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- S/nab
- description
- Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)
- interventionNames
- Drug: S1 or Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Gem/nab
- description
- Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)
- interventionNames
- Drug: S1 or Gemcitabine
Primary outcomes (1)
- measure
- PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmation of pancreatic adenocarcinoma * Distant metastatic or unresctable locally advanced diseases * CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment * At least one lesion measurable by RECIST v1.1 criteria * Life expectancy\> 3 months * No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion) * No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone) * Pain must be monitored before inclusion * 18 years \< age \< 70 * Performance status: 0-1 * ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL * ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found * Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), * creatinine \< 120 μmol/L, or MDRD creatinine clearance \> 60 mL/min * Patient information and signature of informed consent Exclusion Criteria: * Concurrent other effective treatment (including radiotherapy) * Resectable patients * Allergy history to other drugs in the same class patients with pregnancy or lactation * Known severe internal medical diseases * Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia * Immunocompromised patients, such as HIV positive * Uncontrollable mental illness * Other conditions the researchers considered ineligible for the study
References
Publications (3)
- RESULTVon Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16. PMID 24131140
- RESULTUeno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1. PMID 23547081
- RESULTXu Y, Guo X, Fan Y, Wang D, Wu W, Wu L, Liu T, Xu B, Feng Y, Wang Y, Lou W, Zhou Y. Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. Jpn J Clin Oncol. 2018 Jun 1;48(6):535-541. doi: 10.1093/jjco/hyy063. PMID 29718363