The phase 2 study of neoadjuvant chemotherapy of GAS for biological borderline resectable pancreatic cancer.

The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer. - The phase 2 study GAS for biological borderline resectable pancreatic cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061180009

Enrollment

Registered

2018-12-07

Start date

2019-03-02

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

Biological borderline resectable pancreatic cancer

Interventions

Patients were assigned to the following levels of GAS regimens. Nab-paclitaxel was administered intravenously at 125 mg/m2, followed by intravenous gemcitabine at 1000 mg/m2. A daily dose of S1 was de

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) A histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma (2) No distant metastasis (3) Tumor with no contact with the major arteries including the superior mesenteric artery, celiac artery, or common hepatic artery on pretreatment computed tomography (CT) (4) Tumor with no contact or less than 180 degrees contact with portal vein (5) More than 100 U/ml of pretreatment serum CA19-9 level (6) Initial treatment (7) 0 or 1 of Performance status (ECOG) (8) Age between 20 and 79 (9) Adequate hematological, hepatic, and renal functions by hemoglobin >=9.0 g/dl, leucocytes >=3,000 /mm2 and ==1,500 /mm2, platelets >=100,000 /mm2, total bilirubin =<2.0mg/dl, aspartate aminotransferase and alanine aminotransferase =<Normal upper limit x2.5, serum creatinine =<1.5mg/dl (10)The willingness to sign a written informed consent before registration

Exclusion criteria

Exclusion criteria: 1.Severe allergy for protocol drugs 2.History of active malignant disease within 5 years 3.Active infectious disease 4.More than Grade2 of neuropathy 5.Ileus 6.Active interstitional pneumonia 7.Uncontrolable ascites and pleural effusion 8.Uncontrolable diabetes 9.Uncontrolable heart diseases 10.History of sevese neurological diseases 11.Severe diarrhea 12.Pregnancy or possibility of pregnancy 13.Others who were judged to be not appreciated for participation to this clinical trial by attending physician

Design outcomes

Primary

Measure	Time frame
Two-year survival rate and median survival time after initiation of protocol therapy	—

Secondary

Measure	Time frame
- Disease free survival after initiation of protocol therapy - Adverse events - Postoperative complication with more than grade 3 - Response rate and normalization rate of tumor markers after neoadjuvant chemotherapy - Histological response (Evans grade) - Curative resection rate - Short time outcomes after surgical resection - Reoperation rate, readmission rate and mortality - Initiation and completion rate of adjuvant chemotherapy - Dose intensity	—

Measure

Time frame

- Disease free survival after initiation of protocol therapy - Adverse events - Postoperative complication with more than grade 3 - Response rate and normalization rate of tumor markers after neoadjuvant chemotherapy - Histological response (Evans grade) - Curative resection rate - Short time outcomes after surgical resection - Reoperation rate, readmission rate and mortality - Initiation and completion rate of adjuvant chemotherapy - Dose intensity

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Contacts

Public ContactKenjiro Okada

Hiroshima University Hospital

kenokada@hiroshima-u.ac.jp+81-82-257-5216

Outcome results

None listed

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