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Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer (ASAGPAC)

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

nanoparticle albumin-bound paclitaxel

Gemcitabine

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring advanced pancreatic cancer, nanoparticle albumin-bound paclitaxel, S-1, gemcitabine

Eligibility Criteria

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

Inclusion Criteria:

Signed informed-consent form.
Age no less than 18 years.
Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
Patients must have received no previous chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
At least 4 weeks since completion of the last operation except for diagnostic biopsy.
At least 4 weeks since completion of radiotherapy to lesions.
Not suitable for local treatment.
Adequate liver/bone marrow function.
Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
Compliant, and can be followed up regularly.

Exclusion Criteria:

Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
Pregnant or breast-feeding female, or not willing to take contraception measures during study.
Serious infection requiring antibiotics intervention during recruitment.
Allergic to study drug.
More than grade 1 neuropathy.
Uncontrolled brain metastasis or mental illness.
Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
Other malignancy within 5 years.
Can't be followed up or obey protocol.
Ineligible by the discretion of the investigator.

Sites / Locations

Peking University Cancer Hospital and InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AS：Nanoparticle albumin-bound paclitaxel，S-1

AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine

Arm Description

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle. S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.

Outcomes

Primary Outcome Measures

Objective response rate

Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).

Secondary Outcome Measures

Objective response rate of primary tumor

Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).

Progression-free survival

Measure of time from study treatment to disease progression or death.

Overall survival

Measure of time from study treatment to patient's death or lost to follow-up.

Disease control rate

The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).

The incidence of treatment related emergent adverse events（Safety and Tolerance）

Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version

Full Information

NCT ID

NCT03636308

First Posted

August 1, 2018

Last Updated

August 15, 2018

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT03636308

Brief Title

Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer

Acronym

ASAGPAC

Official Title

Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Patients With Advanced Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 17, 2018 (Actual)

Primary Completion Date

August 1, 2020 (Anticipated)

Study Completion Date

August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Detailed Description

Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

6. Conditions and Keywords

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

Pancreatic Cancer

Keywords

advanced pancreatic cancer, nanoparticle albumin-bound paclitaxel, S-1, gemcitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AS：Nanoparticle albumin-bound paclitaxel，S-1

Arm Type

Experimental

Arm Description

Arm Title

AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine

Arm Type

Active Comparator

Arm Description

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.

Intervention Type

Drug

Intervention Name(s)

nanoparticle albumin-bound paclitaxel

Other Intervention Name(s)

nab-paclitaxel, Abraxane, ABI-007

Intervention Description

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.

Intervention Type

Drug

Intervention Name(s)

Intervention Description

S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

Gemcitabine is given at 1000mg/m2 intravenously on d1 and 8 of each 21 day cycle.

Primary Outcome Measure Information:

Title

Objective response rate

Description

Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).

Time Frame

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 Outcome Measure Information:

Title

Objective response rate of primary tumor

Description

Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).

Time Frame

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

Title

Progression-free survival

Description

Measure of time from study treatment to disease progression or death.

Time Frame

up to 15 months

Title

Overall survival

Description

Measure of time from study treatment to patient's death or lost to follow-up.

Time Frame

up to 2 years

Title

Disease control rate

Description

The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).

Time Frame

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

Title

The incidence of treatment related emergent adverse events（Safety and Tolerance）

Description

Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version

Time Frame

Until 28 days after the deadline of enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed-consent form. Age no less than 18 years. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks. Patients must have received no previous chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease. At least 4 weeks since completion of the last operation except for diagnostic biopsy. At least 4 weeks since completion of radiotherapy to lesions. Not suitable for local treatment. Adequate liver/bone marrow function. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end. Compliant, and can be followed up regularly. Exclusion Criteria: Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease. Pregnant or breast-feeding female, or not willing to take contraception measures during study. Serious infection requiring antibiotics intervention during recruitment. Allergic to study drug. More than grade 1 neuropathy. Uncontrolled brain metastasis or mental illness. Congestive heart failure, uncontrolled cardiac arrhythmia, etc. Other malignancy within 5 years. Can't be followed up or obey protocol. Ineligible by the discretion of the investigator.

Central Contact Person:

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

Jun Zhou

Phone

861088196561

13366152815@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lin Shen, Professor

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Cancer Hospital and Institute

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhou, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33191450

Citation

Zong Y, Yuan J, Peng Z, Lu M, Wang X, Shen L, Zhou J. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study. J Cancer Res Clin Oncol. 2021 May;147(5):1529-1536. doi: 10.1007/s00432-020-03442-0. Epub 2020 Nov 15.

Results Reference

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Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer

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