NCT03815461

Brief Summary

This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

4.3 years

First QC Date

January 23, 2019

Last Update Submit

January 24, 2019

Conditions

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    up to 2.5 years

Secondary Outcomes (4)

  • R0 resection rate

    6 months

  • Overall survival rate

    2 years

  • Overall survival

    up to 2.5 years

  • Adverse reaction rate

    up to 2.5 years

Study Arms (1)

experiment group

EXPERIMENTAL

Nab-paclitaxel+S-1

Drug: Nab-paclitaxel and S-1

Interventions

Nab-paclitaxel and S-1DRUG

Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.

experiment group

Eligibility Criteria

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

You may qualify if:

  • patient compliance is good, the research process of this study can be understood, and written informed consent is signed;
  • Age ≥ 18 years old, ≤ 75 years old;
  • Histologically or cytologically confirmed pancreatic adenocarcinoma；
  • no prior treatment;
  • Based on imaging findings, MDT decided patients intoborderline resectable (group A) or unresectable (group B) (according to the resectability assessment criteria in the 2018 Pancreatic Cancer Comprehensive Care Guidelines);
  • ECOG\<2;
  • Bone marrow function: hemoglobin (HGB) ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 100 × 109 / L;
  • Liver function: ALT, AST ≤ 2.5 × upper limit of normal (ULN), if there is liver metastasis, ALT, AST ≤ 5 × ULN; serum total bilirubin \< 1.5 × ULN;
  • Renal function: serum creatinine is within normal range;
  • Patients without biliary obstruction, patients requiring biliary stent implantation must be completed at least 7 days prior to enrollment;
  • Non-pregnant and lactating women, women of reproductive age/male should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment;
  • No contraindication to the use of S-1and albumin-bound paclitaxel.

You may not qualify if:

  • Patients who have had other malignant tumors within 5 years (except for cured cervical cancer in situ or non-melanoma skin cancer);
  • Interstitial pneumonia or pulmonary fibrosis;
  • Severe pleural effusion or ascites;
  • Watery diarrhea;
  • There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active period, people who have diabetes and poorly controlled by hypoglycemic drugs, clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder;
  • Current or previous patients with grade II peripheral neuropathy;
  • Abnormal digestive tract or metabolic function, which may affect the s-1 absorber;
  • Participated in other clinical researchers within 4 weeks prior to enrollment;
  • Patients who have undergone organ transplantation;
  • Patients considered by the investigator to be unfit for this trial.

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)

Study Officials

  • Zhou Aiping

    National Cancer Center/Cancer Hospital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhou Aiping

CONTACT

+86 13691161998zhouap1825@126.com

Zhou Aiping

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cancer Hospital & Institute

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 24, 2019

Study Start

February 1, 2019

Primary Completion

June 1, 2023

Study Completion

October 2, 2023

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

CN(1)