NCT05919381

Gentuximab Combined With Paclitaxel Compared With Placebo Combined With Paclitaxel for Gastric Adenocarcinoma.

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: Phase 3
• Study type: Interventional
• Enrollment: 752 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

It was planned to enroll 752 subjects, grouped according to a 1:1 ratio, with 376 cases each in the experimental group and the control group. Screening period: Screening period assessments were performed within 28 days prior to randomization. Patients are screened after signing the informed consent form (ICF), complete relevant laboratory tests and imaging evaluations (including physical examination, vital signs, height, weight, ECOG score, laboratory tests, 12-lead ECG, echocardiography, chest, abdomen, pelvic contrast/contrast CT and head enhancement MRI, whole body bone scan, etc.), and subjects who meet the inclusion criteria and do not meet the exclusion criteria can be enrolled. Treatment period: All eligible participants were randomly assigned to the following two groups in a 1:1 ratio based on stratified factors (time to randomization \< 6 months or ≥ months from the start of first-line therapy): 1. Test group: Gentuximab injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel injection 80 mg/m2/time, D1, 8, 15 intravenous drip, every 28 days. 2. Control group: placebo 8 mg/kg, D1, 15 intravenous drip, combined with paclitaxel injection 80 mg/m2/time, D1, 8, 15 intravenous drip, every 28 days. Efficacy and quality of life scores were assessed every 8 weeks ± 7 days according to RECIST 1.1, including chest, abdomen, and pelvis. The safety profile of subjects throughout treatment was evaluated according to NCI-CTCAE V 5.0 criteria, including vital signs, physical examination, ECOG score, laboratory tests, 12-lead ECG, echocardiogram, adverse events, serious adverse events, etc. Follow-up periods: Follow-up periods include safety and survival follow-up, immediately after the last study drug is completed. Safety follow-up: All subjects had a safety follow-up within 28±5 days after the last dose or before starting new antitumor therapy (except for subjects withdrawing informed consent, voluntary withdrawal, loss to follow-up, death, etc.), and performed vital signs, physical examination, weight, ECG score, 12-lead ECG, laboratory tests, etc. (see Table 1.3-1 for details), and recorded concomitant medication and adverse events. If safe follow-up is less than 14 days from the end of treatment (EOT) visit, EOT visit can be an alternative to safe follow-up without repeating. Survival follow-up: For any subject who ends treatment due to non-disease progression (and does not take other antitumor therapy), it is still necessary to return to the hospital every 8 weeks ± 7 days according to the original tumor evaluation plan for tumor imaging evaluation and life scale evaluation until disease progression, start of new antitumor therapy, withdrawal of informed consent, voluntary withdrawal, loss to follow-up, death, etc. For participants whose disease has progressed or who have started new antineoplastic therapy, survival follow-up is recorded every 8 weeks ±7 days from the time of notification of disease progression or initiation of new antineoplastic therapy (telephone follow-up) and details of subsequent treatment regimens (antineoplastic therapy received after the end of the study drug) until death, loss to follow-up, or the end of the study (whichever occurs first).

Conditions

• Adenocarcinoma of Stomach

Interventions

Type	Name	Description
DRUG	Gentuximab Injection	Gentuximab Injection 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days.
DRUG	Gentuximab Injection Placebo	Gentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days.

Timeline

• Start date: 2022-05-30
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2023-06-26
• Last updated: 2023-06-26

Locations

1 site across 1 country: China