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PENETRATE

Randomized phase III study of S-1 based chemotherapy plus nivolumab versus S-1 based chemotherapy alone for patients with locally advanced/borderline resectable pancreatic cancer (Investigator initiated trial)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080225361
Enrollment
216
Registered
2020-08-25
Start date
2020-11-19
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 cancer

Interventions

Sponsors

-
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer. 2) Patients who confirmed unresectable locally advanced or borderline resectable pancreatic cancer 3) The longest diameter of tumor does not exceed 10 cm by CT image 4) No sign of direct tumor invasion into gastrointestinal tract 5) Age 20 years old or older 6) Performance Status:0-1(ECOG) 7) No past history of surgery or chemotherapy for pancreatic cancer 8) No past history of radiation therapy to the abdomen 9) Sufficient organ functions

Exclusion criteria

Exclusion criteria: 1) Synchronous multiple cancers 2) Infectious disease to be treated 3) Past history of systemic steroid therapy (>10 mg/body of prednisolone) within 14 days 4) Active peptic ulcer 5) Interstitial pneumonia, pulmonary fibrosis, or inflammatory lung disease confirmed by medical history or imaging test 6) Pleural, pericardial, or abdominal effusion

Design outcomes

Primary

MeasureTime frame
efficacy Overall Survival

Secondary

MeasureTime frame
efficacy Progression Free Survival, Response rate etc safety Incidence of Adverse event, Incidence of Serious adverse event etc

Countries

Japan

Contacts

Public ContactMasashi Kanai

Kansai Medical University Hospital

prj-penetrate-core@eps.co.jp+81-72-804-0101

Outcome results

None listed

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