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Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

NCT02401971 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2015-03-30

No results posted yet for this study

Summary

Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.

Conditions

Interventions

DRUG

Thalidomide

Given orally

DRUG

CPT-11

Given Ivgtt

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Henan Provincial People's Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • The First Affiliated Hospital of Henan University of Science and Technology

    collaborator OTHER

  • Wang Jufeng

    lead OTHER

Principal Investigators

  • Wang Jufeng · Henan Cancer Hospital

  • Qin Yanru · The First Affiliated Hospital of Zhengzhou University

  • Zhou Yun · Henan Provincial People's Hospital

  • Zhang Zhongmian · Second Affiliated Hospital of Zhengzhou University

  • Guo Yanzhen · The First Affiliated Hospital of Henan University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-08-31
Completion
2018-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT02401971 on ClinicalTrials.gov