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

Primary Purpose

Locally Advanced Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel and S-1

About this trial

This is an interventional treatment trial for Locally Advanced Pancreatic Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

≥ 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;

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nab-paclitaxel and S-1

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Objective Response Rate (ORR)

Refers to the proportion of patients with partial tumor remission (PR) and complete remission (CR).

Full Information

NCT ID

NCT03885219

First Posted

February 20, 2019

Last Updated

March 8, 2020

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03885219

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nab-paclitaxel and S-1

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel and S-1

Intervention Description

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.

Primary Outcome Measure Information:

Title

6-month progression-free survival (PFS)

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Refers to the proportion of patients with partial tumor remission (PR) and complete remission (CR).

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: ≥ 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

TaiPing Zhang

Phone

13520132976

Tpingzhang@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

YueJuan Cheng

Phone

861069158315

cnchengyuejuan@yahoo.com

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YueJuan Cheng

Phone

861069158315

cnchengyuejuan@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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