Clinical trial · Interventional
Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial
- 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)
Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management. Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.
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 Cancer Stage II | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel and Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel and gemcitabine
- description
- ARM A: nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle
- interventionNames
- Drug: Nab-paclitaxel and Gemcitabine
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- description
- ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
- interventionNames
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Progression Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age \>18 \< 75 years * Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer * At least one lesion measurable with CT or MRI scan * Performance Status (ECOG) 0-1 at study entry * Life expectancy of at least 3 months * Adequate marrow, liver and renal function * Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported) Exclusion Criteria: * Previous chemotherapy or radiotherapy for pancreatic cancer * Severe cardiovascular disease * Thrombotic or embolic events * Acute or subacute intestinal occlusion or history of inflammatory bowel disease * Known hypersensitivity to study drug * Known drugs or alcohol abuse * Pregnant or breastfeeding women * Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization * Unable to sign informed consent
References
Publications (1)
- DERIVEDCascinu S, Berardi R, Bianco R, Bilancia D, Zaniboni A, Ferrari D, Mosconi S, Spallanzani A, Cavanna L, Leo S, Negri F, Beretta GD, Sobrero A, Banzi M, Morabito A, Bittoni A, Marciano R, Ferrara D, Noventa S, Piccirillo MC, Labianca R, Mosconi C, Casadei Gardini A, Gallo C, Perrone F. Nab-paclitaxel/gemcitabine combination is more effective than gemcitabine alone in locally advanced, unresectable pancreatic cancer - A GISCAD phase II randomized trial. Eur J Cancer. 2021 May;148:422-429. doi: 10.1016/j.ejca.2021.02.023. Epub 2021 Mar 31. PMID 33812334