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COMPLETED
NCT04053205
PHASE1/PHASE2

A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer

Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study. Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.

Official title: An Multi-center, Open-label Phase Ib/II Study of Gentuximab Injection + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer to Evaluate Tolerability, Safety, Efficacy and Pharmacokinetics.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2019-11-05

Completion Date

2020-09-20

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

Gentuximab

Administered intravenously (IV)

DRUG

Paclitaxel

Administered intravenously (IV)

Locations (12)

Fujian Tumor Hospital

Fuzhou, Fujian, China

The Sixth Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Affiliated Tumor Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Hangzhou, Zhejiang, China

Shanghai East Hospital

Shanghai, China

Shanghai First People's Hospital

Shanghai, China