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

NCT03636308 | Unknown Phase 2

• 1 other identifier: ASAG01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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 Outcomes (5)

• Objective response rate of primary tumor

  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

• Progression-free survival

  up to 15 months

• Overall survival

  up to 2 years

• Disease control rate

  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

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

  Until 28 days after the deadline of enrollment

Study Arms (2)

AS：Nanoparticle albumin-bound paclitaxel，S-1

EXPERIMENTAL

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.

Drug: nanoparticle albumin-bound paclitaxel; Drug: S1

AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine

ACTIVE COMPARATOR

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.

Drug: nanoparticle albumin-bound paclitaxel; Drug: Gemcitabine

Interventions

nanoparticle albumin-bound paclitaxel DRUG

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.

Also known as: nab-paclitaxel, Abraxane, ABI-007

AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine; AS：Nanoparticle albumin-bound paclitaxel，S-1

S1 DRUG

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.

AS：Nanoparticle albumin-bound paclitaxel，S-1

Gemcitabine DRUG

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

AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (2)

• Jin M, Liu HL, Xue J, Ma H, Liu JL, Lin ZY, Wang J, Bao LQ, Luo ZG, Yu XJ, Li S, Hu JL, Zhang T. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer: a multicenter, randomized, phase II study. Oncologist. 2024 Oct 3;29(10):e1406-e1418. doi: 10.1093/oncolo/oyae171.

  PMID: 38990195 DERIVED

• 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.

  PMID: 33191450 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Taxes; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; S 1 (combination); Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lin Shen, Professor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhou

CONTACT

861088196561; 13366152815@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 17, 2018
• Study Start: July 17, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)