NCT03415802

Brief Summary

Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2019

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

January 24, 2018

Last Update Submit

January 29, 2021

Conditions

Advanced Pancreatic Cancer

Keywords

Nab-PaclitaxelS-1Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate（ORR）

    CR+PR was defined as objective response rate (ORR)

    6 month

Secondary Outcomes (4)

  • DCR

    6 month

  • PFS

    6 month

  • OS

    1 year

  • Safety profile: Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer

    1 year

Study Arms (1)

Nab-paclitaxel Plus S-1

EXPERIMENTAL

Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area\<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area\>1.5 m2; D1-14, q3w)

Drug: Nab-paclitaxel and S-1

Interventions

Nab-paclitaxel and S-1DRUG

Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-14, q3w)

Also known as: Abraxane,Tegafur, Gimeracil and Oteracil Porassium
Nab-paclitaxel Plus S-1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age, years: 18-75
  • Histologically and cytologically confirmed advanced pancreatic cancer , inresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
  • Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
  • Laboratory examination within 14 days before entering the study should meet following requirements: ANC ≥ 1.5 x 10\^9/L; PLT ≥ 100 x 10\^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
  • Both male and female subjects of potential fertility have to agree effective birth control during the entire study
  • Informed consent

You may not qualify if:

  • Concurrent other effective treatment (including radiotherapy)
  • Resectable patients
  • Allergy history to other drugs in the same class patients with pregnancy or lactation
  • Known severe internal medical diseases
  • Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
  • Immunocompromised patients, such as HIV positive
  • Uncontrollable mental illness
  • Other conditions the researchers considered ineligible for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College

Beijing, China

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxelS 1 (combination)Albumin-Bound PaclitaxelTegafurgimeracil

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsFluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Aiping Zhou, Doctor

    National Cancer Center/Cancer Hospital, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
UNKNOWN
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 30, 2018

Study Start

May 11, 2015

Primary Completion

July 11, 2017

Study Completion

July 11, 2019

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

CN(1)