Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer

NCT03885219 | Unknown Phase 2

• 1 other identifier: HS-1751
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival (PFS)

  The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the registration.

  6 months

Secondary Outcomes (1)

• Objective Response Rate (ORR)

  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.

Study Arms (1)

nab-paclitaxel and S-1

EXPERIMENTAL

chemotherapy of Nab-Paclitaxel and S-1, repeat 21 days for up to 8 cycles. The following treatment including pancreatectomy, continuing same chemotherapy, S-1 maintenance therapy, or radiotherapy will be decided after discussion between physicians and patients.

Drug: Nab-paclitaxel and S-1

Interventions

Nab-paclitaxel and S-1 DRUG

Nab-paclitaxel: 120 mg/m2 d1, 8, S-1:Body surface area \< 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 , \< 1.5 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14; repeat every 21 days.

nab-paclitaxel and S-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ≥ Grade 2 existing peripheral neuropathy;
• 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.
• Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
• 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.
• Not able to take medicine orally.
• Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
• Participation in other clinical trial within 30 days before the first dose of the drug;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; S 1 (combination)

Central Study Contacts

TaiPing Zhang

CONTACT

13520132976; Tpingzhang@yahoo.com

YueJuan Cheng

CONTACT

861069158315; cnchengyuejuan@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: March 21, 2019
• Study Start: May 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 10, 2020

Record last verified: 2020-02

Locations

CN (1)