Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma

Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma - PDAC-GS/GA-rP2, CSGO-HBP-015

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021484

Enrollment

100

Registered

2016-04-01

Start date

2016-04-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic ductal adenocarcinoma

Interventions

Arm 1:Gem+S-1 q3wx2times Patients receive S-1(80mg/m2/day,day1-14) plus Gemcitabine(1000mg/m2,day1,15) every 3 weeks,2 times. Arm 2:Gem+nab-PTX q4wx2times Patients receive nab-PTX(125mg/m2, day1,1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer. 2. Patients of age =>20 3. Performance Status:0-1(ECOG) 4. Resectable pancreatic cancer 5. Life expectancy more than 6 months. 6. Sufficient organ functions. (1) neutrophils >=1,500/mm3 (2) platelets >=100,000/mm3 (3) hemoglobin >=9.0g/dl (4) AST(GOT)/ALT(GPT) <=150IU (5) total bilirubin <=2.0mg/dl (or <=3.0mg/dl if biliary drainage were present) (6) serum creatinine <=1.2mg/dl (7) creatinine clearance>=60ml/min 7. No treatment before application for this tumor 8. Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Unresectable pancreatic cancer 2) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. 3) Watery diarrhea 4) Severe infection 5) Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 6) Massive pleural or abdominal effusion. 7) Metastasis to central nervous system. 8) Active synchronous or metachronous malignancy other than carcinoma in situ. 9) Regular use of frucitocin, fenitoin or warfarin 10) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 11) Severe mental illness 12) Severe allergy for drugs 13) Patients who are judged inappropriate for the entry into the study by the investigator.

Design outcomes

Primary

Measure	Time frame
Progression free survival time	—

Secondary

Measure	Time frame
Rate of curative resection, dose intensity, radiological/histological responses, recurrence type (if develop), overall survival and adverse events	—

Countries

Japan

Contacts

Public ContactDaisaku Yamada

Graduate school of medicine, Osaka university Department of Gastroenterological surgery

dyamada@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026