# APACT

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

## TL;DR

APACT tested whether adding nab-paclitaxel to gemcitabine after pancreatic surgery delays relapse; by the independent radiologists' reading it did not (19.4 against 18.8 months), although patients on the combination lived about four months longer at five years, so the regimen is not a formal adjuvant standard.

## Summary

APACT randomised 866 treatment-naive patients with resected pancreatic ductal adenocarcinoma to nab-paclitaxel 125 mg/m2 with gemcitabine 1,000 mg/m2 or gemcitabine alone on days 1, 8 and 15 of six 28-day cycles; 287 of 432 and 310 of 434 completed treatment. At the primary cut-off (December 2018, median follow-up 38.5 months) independently assessed disease-free survival was 19.4 against 18.8 months (hazard ratio 0.88, 95 percent confidence interval 0.729 to 1.063; p 0.18), so the trial missed its primary endpoint; investigator-assessed disease-free survival was 16.6 against 13.7 months (hazard ratio 0.82; p 0.02). Overall survival favoured the combination at every cut: 40.5 against 36.2 months (hazard ratio 0.82; p 0.045) at the primary analysis and 41.8 against 37.7 months (hazard ratio 0.80; p 0.0091) at five years with 88 percent of events. Grade 3 or worse treatment-emergent adverse events occurred in 86 against 68 percent, with two treatment-related deaths per arm. The trial recruited at six UK sites (Addenbrooke's Cambridge, Glasgow Royal Infirmary and Weston Park Sheffield among them). Because the primary endpoint was missed the regimen sits below modified FOLFIRINOX and gemcitabine plus capecitabine in guidelines, and the discordance between central and local reading of relapse became a design lesson for later adjuvant trials.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: ABI-007-PANC-003
- Registry id: NCT01964430
- Phase: 3
- Setting: Resected pancreatic ductal adenocarcinoma at 179 sites in 21 countries: six cycles of adjuvant nab-paclitaxel plus gemcitabine against gemcitabine alone, with independently assessed disease-free survival as the primary endpoint
- Sponsor: Celgene (Bristol Myers Squibb)
- Enrolled: 866
- Result: Independently assessed disease-free survival 19.4 against 18.8 months (hazard ratio 0.88; p 0.18), primary endpoint not met; overall survival 41.8 against 37.7 months at five years (hazard ratio 0.80; p 0.0091).
- Outcomes: Disease-free survival (independent review): Adjuvant nab-paclitaxel + gemcitabine 19.4 months vs Adjuvant gemcitabine 18.8 months, HR 0.88; Overall survival (5-year follow-up, 88% mature): Adjuvant nab-paclitaxel + gemcitabine 41.8 months vs Adjuvant gemcitabine 37.7 months, HR 0.8

## Notes

- UK sites (registry, 6): Addenbrooke's Hospital Cambridge, Glasgow Royal Infirmary, Weston Park Hospital Sheffield and their local institution entries.

## Sources

- ClinicalTrials.gov NCT01964430: https://clinicaltrials.gov/study/NCT01964430
- Tempero et al., APACT (JCO 2023): https://doi.org/10.1200/JCO.22.01134

## Connected records

- cancers: [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Gemcitabine + nab-paclitaxel](https://onco.cc/drugs/gemcitabine-nab-paclitaxel/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- terms: [Pancreatic cancer: the failed and stopped programmes and why](https://onco.cc/terms/pancreatic-failed-programmes/)
- trials: [ESPAC-4](https://onco.cc/trials/espac-4/), [PRODIGE 24 / CCTG PA6](https://onco.cc/trials/prodige-24/)

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