Clinical trial NCT03885219: Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer
Official title: Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Pancreatic Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 60
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: This study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.


Eligibility criteria: Inclusion Criteria:

1. Patients have good compliance, can understand the research process of this study, and sign a written informed consent
2. Patients with pathologically confirmed pancreatic adenocarcinoma.
3. Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
4. Patients with locally advanced pancreatic cancer ( NCCN Version 1，2019 criteria).
5. ECOG PS 0-1;
6. Tumor size is measurable according to RECIST1.1 criteria
7. Expected survival over 3 months;
8. Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
9. Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
10. No contraindications to the use of S-1 and nab-paclitaxel.

Exclusion Criteria:

1. ≥ Grade 2 existing peripheral neuropathy;
2. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
3. Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
4. Severe, active co-morbidity, defined as follows:

   Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
5. Not able to take medicine orally.
6. Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
7. Participation in other clinical trial within 30 days before the first dose of the drug;

Primary outcomes:
measure: 6-month progression-free survival (PFS)
timeFrame: 6 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: