A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion

A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion - A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057114

Enrollment

Registered

2025-02-21

Start date

2025-02-19

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 body/tail cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically diagnosed with pancreatic body/tail adenocarcinoma, radiologically involving splenic artery and/or vein, and consistent with NCCN guideline (Version 1.2020) resectable-arterial, resectable-venous. 2. Measurable lesion. 3. First-line treatment. 4. PS(ECOG) 0-1. 5. Equal to or more than 18 years old 6. The following criteria must be satisfied in laboratory tests within 14 days of registration: WBC count equal to or less than 12,000/mm3, Neutrophil count equal to or more than 1,500/mm3, Hb equal to or more than9.0g/dl, Plt equal to or more than 100,000/mm3, T.Bil less than2.0mg/dl(equal to or less than 3.0mg/dl in biliary drainage case), Serum Cr equal to or less than1.5 mg/dl, AST,ALT equal to or less than 2.5xULN. 7. Written informed consent to participate in this study was also required.

Exclusion criteria

Exclusion criteria: i) Severe drug hypersensitivity. ii) Multiple primary cancers within five years. iii) Severe infection. iv) Severe peripheral neuropathy of Grade 2 or more. v) Interstitial pneumonia or pulmonary fibrosis. vi) Uncontrollable pleural effusion or ascites. vii) Uncontrollable diabetes mellitus. viii) Uncontrollable heart failure, angina, hypertension and arrhythmia. ix) Severe neurological/psychological symptoms. x) Watery diarrhea. xi) Pregnant or lactating women or women with unknown or suspected pregnancy. xii) Inappropriate patients for enrollment based on the judgement of the researchers. xiii) Diagnosed as resectable/unresectable pancreatic carcinoma according to NCCN guideline (Version 1.2020). xiv) Active hepatitis B.

Design outcomes

Primary

Measure	Time frame
Overall survival time after protocol therapy.	—

Secondary

Measure	Time frame
1. Recurrence free survival time after protocol therapy. 2. Safety of protocol therapy (CTCAE Ver 4.0.) 3. Incicence of morbidity (equal to more than grade I of Clavien Dindo classification). 4. Response rate, disease control rate. 5. Preoperative/postoperative tumor marker (CA19-9, CEA), rate of normalization. 6. Reduction rate of SUVmax value on PET-CT(limited to available patients) 7. Chemotherapeutic effect (grade based on Evans classification). 8. Resection rate. 9. R0 resection rate. 10. Surgical data(operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of re-admission, mortality). 11. Incoidence of all morbidity. 12. Rate of patient undergo postoperative adjuvant therapy (entry rate, completion rate). 13. Dose intensity	—

Measure

Time frame

1. Recurrence free survival time after protocol therapy. 2. Safety of protocol therapy (CTCAE Ver 4.0.) 3. Incicence of morbidity (equal to more than grade I of Clavien Dindo classification). 4. Response rate, disease control rate. 5. Preoperative/postoperative tumor marker (CA19-9, CEA), rate of normalization. 6. Reduction rate of SUVmax value on PET-CT(limited to available patients) 7. Chemotherapeutic effect (grade based on Evans classification). 8. Resection rate. 9. R0 resection rate. 10. Surgical data(operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of re-admission, mortality). 11. Incoidence of all morbidity. 12. Rate of patient undergo postoperative adjuvant therapy (entry rate, completion rate). 13. Dose intensity

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Countries

Japan

Contacts

Public ContactKen-ichi Okada

Tokai University Scool of Medicine Department of Gastroenterological Surgery

kokada@tokai.ac.jp0463931121

Outcome results