NIPH Clinical Trials Search

JRCT ID: jRCTs061180009

Registered date:07/12/2018

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBiological borderline resectable pancreatic cancer
Date of first enrollment02/03/2019
Target sample size50
Countries of recruitment
Study typeInterventional
Intervention(s)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 defined based on the patient's body surface area as follows:<1.25m2, 60mg;1.25-1.5m2,80mg;>1.5m2,100mg. S1 administered orally twice a day on days 1-7. The treatment cycle was repeated every 2 weeks. After 6 cycles of the GAS chemotherapy regimen, patients were reevaluated to assess resectability and response to the treatment.


Primary OutcomeTwo-year survival rate and median survival time after initiation of protocol therapy
Secondary Outcome- 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
Include 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 =<12,000 /mm2, neutrophils >=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
Exclude criteria1.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

Related Information


Public contact
Name Kenjiro Okada
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima 734-8551, JAPAN Hiroshima Japan 734-8551
Telephone +81-82-257-5216
Affiliation Hiroshima University Hospital
Scientific contact
Name Kenichiro Uemura
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima 734-8551, JAPAN Hiroshima Japan 734-8551
Telephone +81-82-257-5216
Affiliation Hiroshima University Hospital