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Feasibility and potential benefits of preoperative chemotherapy with Gemcitabine+nab/Paclitaxel in patients with resectable pancreatic cancer: a multicenter phase I/II trial (APCS-01 study).

Feasibility and potential benefits of preoperative chemotherapy with Gemcitabine+nab/Paclitaxel in patients with resectable pancreatic cancer: a multicenter phase I/II trial (APCS-01 study). - Multicenter phase I/II study of preoperative chemotherapy with Gemcitabine and nab/Paclitaxel for resectable pancreatic cancer (APCS-01).

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033901
Enrollment
30
Registered
2018-09-15
Start date
2018-09-15
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

resectable pancreatic cancer

Interventions

Regimen of the chemotherapy: 1000mg/2 of Gemcitabine and 125mg/m2 of nab-Paclitaxel are administered. Schedule: Gemcitabine and nab-Paclitaxel are administered once a week concurrently. A cycle is c

Sponsors

Hirosaki University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adenocarcinoma and adenosquamous carcinoma is confirmed pathologically. 2. No distant metastases are pointed out. 3. Resectability is diagnosed as "Resectable" according to General Rules for the Study of Pancreatic Cancer, 7th edition. 4. Radical surgery is tolerable. 5. No treatment history of pancreatic cancer. 6. Patient over 20 years old. 7. Good performance status (ECOG PS 0-1). 8. Appropriate biliary drainage has been performed when the patient had obstructive jaundice. 9. Main organ's functions are maintained. 10. Informed consent has been obtained in writing by the patient about the trial participation.

Exclusion criteria

Exclusion criteria: 1. Patient with the treatment history of gemcitabine or nab/paclitaxel. 2. R0 resection is judged to be impossible. 3. Patient with sever diarrhea. 4. Patient with sever ascites and pleural effusion. 5. Patient with active other cancer. 6. Patient with sever coexisting disease. 7. Patients with active infectious disease. 8. Patient with remarkable abnormal electrocardiogram or sever cardiac disorder. 9. Patient with severe psychiatric disorder. 10. Pregnant female, lactating female, female who might be pregnant, female who hopes to be pregnant, and male who hopes the partner's pregnancy. 11. Patient with the history of sever medication allergy. 12. Patient with continuous systemic administration of the steroid. 13. Patient with contraindication of gemcitabine and nab-paclitaxel. 14. Patient where the attending doctor judged unsuitable for safely carrying out.

Design outcomes

Primary

MeasureTime frame
relapse-free survival time

Secondary

MeasureTime frame
completion rate of preoperative chemotherapy, over-all survival time, down-staging rate, R0 resection rate, adverse event rate, anti-tumor efficacy

Countries

Japan

Contacts

Public ContactKeinosuke Ishido

Hirosaki University Graduate School of Medicine Department of Gastroenterological Surgery

k-ishido@hirosaki-u.ac.jp0172-39-5079

Outcome results

None listed

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