NCT03083613

Brief Summary

This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response rate.The secondary endpoint of this study is safety,progression-free survival and overall survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started May 2015

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 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

March 14, 2017

Last Update Submit

January 29, 2021

Conditions

Gastric CancerGastroesophageal Junction Adenocarcinoma

Keywords

RaltitrexedPaclitaxelchemotherapyGastric cancerGastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    18-26 months

Secondary Outcomes (2)

  • Overall Survival

    18-26 months

  • Progression-free survival

    18-26 months

Study Arms (1)

Raltitrexed and Paclitaxel

EXPERIMENTAL

All patients receive the combination therapy of Raltitrexed and Paclitaxel for a maximum of 6 cycles Raltitrexed:3mg/m2,d1 Paclitaxel:80mg/m2,d1,d8, Eery 3 weeks

Drug: RaltitrexedDrug: Paclitaxel

Interventions

RaltitrexedDRUG

Raltitrexed:3mg/m2,iv,d1, Every 3 weeks

Also known as: RTX
Raltitrexed and Paclitaxel
PaclitaxelDRUG

Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks

Raltitrexed and Paclitaxel

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
  • Patients failed first-line chemotherapy containing fluoropyrimidines and platinums;
  • ECOG (Eastern Cooperative Oncology Group)performance status 0-1;
  • At least 1 measurable lesion should be present（RECIST1.1）
  • Available Organ function: Neutrophils\>2g/L, Hemoglobin\>9g/L, Blood platelet \>100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)\<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)\<1.0 ULN; Cr \<1.0ULN
  • Signed informed consent.
  • Life expectancy ≥3 months;

You may not qualify if:

  • Previous treatment with Raltitrexed or Paclitaxel;
  • Known history of allergic reaction to Raltitrexed or Paclitaxel;
  • Known brain metastases;
  • Pregnant or breast feeding women;
  • Severe diarrhea,intestinal obstruction;
  • other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
  • Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia;
  • Kown HIV infecton.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, 10000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

raltitrexedPaclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Ai Ping Zhou, Doctor of medcine

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

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
Chief physician

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 20, 2017

Study Start

May 1, 2015

Primary Completion

September 1, 2017

Study Completion

December 1, 2018

Last Updated

February 1, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)