MedTrace Logo

Telatinib in Combination With Capecitabine/ Oxaliplatin in 1st Line Gastric or GEJ Cancer

NCT03817411 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-05-07

No results posted yet for this study

Summary

The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.

Conditions

Interventions

DRUG

Telatinib

300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.

DRUG

Capecitabine

1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).

DRUG

Oxaliplatin

130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.

DRUG

Placebos

300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.

Sponsors & Collaborators

  • Shanghai East Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Taizhou EOC Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Li, M.D. · Shanghai Easter Hospital, Dpt. of Clinical Oncology

  • Tian Shu Liu, M.D. · Shanghai Fudan Zhongshan Hospital, Dpt. of Clinical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2020-03-30
Completion
2021-01-25
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03817411 on ClinicalTrials.gov