Clinical trial NCT04808687: Neoadjuvant Nab-Paclitaxel and S-1 in Resectable Pancreatic Cancer
Official title: Phase II Single-arm Trial of Nab-Paclitaxel and S-1 as Neoadjuvant Treatment of Patients With Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: 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
Secondary outcomes:
measure: R0/R1 resection rate
timeFrame: 2 years
measure: Disease free survival
timeFrame: From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months
measure: Overall survival
timeFrame: 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
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: