Pancreatic Neoplasms
Conditions
Brief summary
There were limited data for nab-paclitaxel and S-1 in pancreatic cancer. To explore the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with resectable pancreatic cancer (stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions ), we designed this study. This study was a single-arm single center prospective phase II clinical study. A total of 72 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1 prior to pancreatectomy. Response was reported according to the Response Evaluation Criteria in Solid Tumors guidelines (RECIST, version 1.1) .The primary endpoint is objective response rate. The secondary endpoints include R0/R1 resection rate, disease free survival, overall survival and safety.
Interventions
DRUGNab paclitaxel and S-1
Nab-Paclitaxel: 125 mg/m2 d1, 8, during each 3-week cycle. S-1: Body surface area \< 1.25 m2, 40 mg bid; Body surface area ≥ 1.25 m2 \< 1.50 m2, 50 mg bid; Body surface area ≥1.5 m2, 60 mg bid, d1-14;during each 3-week cycle.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed-consent form; 2. Treatment-naive PDAC with histological or cytological diagnosis; 3. Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions; 4. Age≥18 years old and ≤70 years old; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. BMI≥18.5 and NRS2002score\<3; 7. Expected survival over 3 months; 8. Spared organ function satisfying the following laboratory data:leucocyte≥3.0x109/L,neutrophils≥1.5x109/L, hemoglobin≥ 9g/dL, platelets ≥100x109/L, total bilirubin ≤ 1.5 ULN; AST and ALT≤ 2.5 ULN; serum creatinine≤1.5ULN; PT and INR≤ 2.5 ULN;
Exclusion criteria
1. Severe Impaired organ functions; 2. Patients who had surgeries, chemotherapy or other treatments before inclusion; 3. Pregnant women or lactating women; 4. Ineligible by the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 24 months | Percentage of patients who achieve partial response (PR) or complete response(CR) based on Response Evaluation Criteria In Solid Tumors (RECIST1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0/R1 resection rate | 2 years | proportion of patients who achieved R0/R1 resection |
| Disease free survival | From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months | The time between operation and the relapse or metastasis of tumors or death |
| Overall survival | From date of randomization until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months | The time between randomization and death from any cause or lost to follow-up |
Countries
China
Contacts
Primary ContactJihui Hao
Outcome results
None listed