NCT05919381 is a Phase 3 clinical trial of Gentuximab Injection in Adenocarcinoma of Stomach, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd..

Who is sponsoring NCT05919381?

NCT05919381 is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd..

What drugs are being tested in NCT05919381?

Interventions in NCT05919381: Gentuximab Injection, Gentuximab Injection Placebo.

What condition does NCT05919381 study?

NCT05919381 studies Adenocarcinoma of Stomach.

Is NCT05919381 still recruiting?

NCT05919381 is currently status unknown. Last updated 16 June 2023.

Last reviewed 2023-06-16 · How we verify

NCT05919381

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-blind, Parallel Controlled Phase III Study of Gentuximab Injection Combined With Paclitaxel Injection Versus Placebo Combined With Paclitaxel Injection for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

Status unknown Phase 3 Last updated 16 June 2023

What this trial tests

Phase 3 trial testing Gentuximab Injection in Adenocarcinoma of Stomach in 752 participants. Status unknown.

Timeline

30 May 2022

Primary endpoint
1 December 2024

1 January 2025

Quick facts

Lead sponsor	Changchun GeneScience Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	752
Start date	30 May 2022
Primary completion	1 December 2024
Estimated completion	1 January 2025
Sites	1 location across China

Drugs / interventions tested

Gentuximab Injection — full drug profile →
Gentuximab Injection Placebo

Conditions studied

Adenocarcinoma of Stomach — all drugs for Adenocarcinoma of Stomach →

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Adenocarcinoma of Stomach. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

OS
Time frame: 36 months.
From date of randomization until the date of first documented death from any cause,assessed up to 36 months.

Sponsor's own description

To evaluate the efficacy and safety of the combination of Gentuximab Injection and Paclitaxel Injection in patients with advanced gastric or gastroesophageal junction adenocarcinoma after first-line treatment failure compared with Placebo and Paclitaxel Injection.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Adenocarcinoma of Stomach

Currently open trials in the same condition.

NCT07353684 — Adebrelimab, Apatinib & SOX for Conversion Therapy in Advanced Gastric/GEJ Cancer · Phase 2 · recruiting
NCT06790238 — POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol After Gastric Surgery (POWER 4 + · active not recruiting

Other Changchun GeneScience Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07534176 — To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . · Phase 1 · not yet recruiting
NCT07476586 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants · Phase 1 · not yet recruiting
NCT07491289 — GS1-144 in Participants With Hepatic Impairment and Healthy Female · Phase 1 · not yet recruiting
NCT07537231 — A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Fe · Phase 1 · not yet recruiting
NCT07366866 — A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults. · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05919381 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Changchun GeneScience Pharmaceutical Co., Ltd.
Last refreshed: 16 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05919381.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing