# NEOLAP

Source: https://onco.cc/trials/neolap/  
OnCo record `neolap` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

NEOLAP asked whether switching to FOLFIRINOX after two months of gemcitabine and nab-paclitaxel converts more inoperable pancreatic cancers to operable ones; about a third to 44 percent were removed with either sequence and survival was similar, so both induction regimens are acceptable.

## Summary

NEOLAP randomised 130 of 168 registered patients (64 to continued nab-paclitaxel plus gemcitabine, 66 to sequential FOLFIRINOX) between November 2014 and April 2018. Surgical exploration was done in 63 and 64 percent; complete macroscopic resection in 23 and 29 patients, a conversion rate of 35.9 percent (95 percent confidence interval 24.3 to 48.9) against 43.9 percent (31.7 to 56.7) (odds ratio 0.72; p 0.38). Median overall survival was 18.5 months against 20.7 months (hazard ratio 0.86; p 0.53), with better histopathological downstaging after FOLFIRINOX (ypT1/2 in 69 against 17 percent). Grade 3 or worse events during induction occurred in 55 and 53 percent, including bile duct obstruction with cholangitis in 9 and 11 percent. The trial underpins the corpus's locally advanced row: four to six months of multi-agent induction, surgical exploration for responders, and no proven advantage of one backbone over the other.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: NEOLAP-AIO-PAK-0113; AIO-PAK-0113
- Registry id: NCT02125136
- Phase: 2
- Setting: Treatment-naive locally advanced pancreatic adenocarcinoma at 28 German centres: after two cycles of nab-paclitaxel plus gemcitabine, two further cycles of the same against four cycles of FOLFIRINOX, all followed by surgical exploration, with the surgical conversion rate as the primary endpoint
- Sponsor: AIO-Studien-gGmbH (German pancreatic cancer group), with Celgene
- Enrolled: 130
- Result: Surgical conversion 35.9 percent with continued nab-paclitaxel plus gemcitabine against 43.9 percent with sequential FOLFIRINOX (odds ratio 0.72; p 0.38); median overall survival 18.5 against 20.7 months (hazard ratio 0.86; p 0.53).
- Outcomes: Surgical conversion rate (complete macroscopic resection): Nab-paclitaxel + gemcitabine x4 35.9% vs Nab-paclitaxel + gemcitabine x2 then FOLFIRINOX x4 43.9%; Overall survival: Nab-paclitaxel + gemcitabine x4 18.5 months vs Nab-paclitaxel + gemcitabine x2 then FOLFIRINOX x4 20.7 months, HR 0.86

## Sources

- ClinicalTrials.gov NCT02125136: https://clinicaltrials.gov/study/NCT02125136
- Kunzmann et al., NEOLAP (Lancet Gastroenterology and Hepatology 2021): https://doi.org/10.1016/S2468-1253(20)30330-7

## Connected records

- cancers: [Locally advanced unresectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/locally-advanced-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [FOLFIRINOX / mFOLFIRINOX](https://onco.cc/drugs/folfirinox/), [Gemcitabine + nab-paclitaxel](https://onco.cc/drugs/gemcitabine-nab-paclitaxel/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/)
- companies: [AIO (Arbeitsgemeinschaft Internistische Onkologie)](https://onco.cc/companies/aio/)
- terms: [Cholangitis: infection of a blocked bile duct](https://onco.cc/terms/acute-cholangitis/), [Resectable, borderline resectable and unresectable](https://onco.cc/terms/resectability/)

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