Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectable Pancreatic Cancer

NCT ID: NCT03850769

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-04-30

Brief Summary

This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.

Conditions

Borderline Resectable Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-paclitaxel and S-1

neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles.

Group Type: EXPERIMENTAL

nab-paclitaxel and S-1

Intervention Type: 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 \< 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;

Interventions

nab-paclitaxel and S-1

Nab-Paclitaxel: 120 mg/m2 d1, 8, S-1: Body surface area \< 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 \< 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;

Intervention Type: DRUG

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 borderline resectable 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

TaiPing Zhang, MD

Role: CONTACT

Tpingzhang@yahoo.com

13520132976

YueJuan Cheng, MD

Role: CONTACT

cnchengyuejuan@yahoo.com

861069158315

Facility Contacts

YueJuan Cheng

Role: primary

cnchengyuejuan@yahoo.com

861069158315

Other Identifiers

HS-1752

Identifier Type: -

Identifier Source: org_study_id