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Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma

NCT05978050 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2024-08-28

No results posted yet for this study

Summary

In order to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel as second-line treatment for recurrent metastatic gastric or esophagogastric junction adenocarcinoma with EGFR over-expression, investigators performed a randomized, double-blind, placebo-controlled phase III clinical trial. Patients will be randomized (1:1) to receive nimotuzumab plus paclitaxel in the experimental group and placebo plus paclitaxel in the control group. The primary endpoint of this study was OS, and according to the results of the RAINBOW-Asia gastric cancer phase III clinical study, the mOS of paclitaxel single-agent second-line treatment for gastric cancer was 7.92 months, assuming that the mOS increased to 10.92 months after the addition of nimotuzumab, Using the survival module in the PASS15 software, the two-sided test level was set α=0.05, β=0.20, enrolled for 2 years, followed up for 1.5 years, the dropout rate was 5%, the sample size including interim analysis was 354 cases. The secondary endpoints are progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), patient reported outcome (PRO), and safety.

Conditions

  • Gastric or Esophagogastric Junction Adenocarcinoma

Interventions

DRUG

nimotuzumab plus paclitaxel

Nimotuzumab injection: 50mg/10ml/stick Paclitaxel: 30mg/5ml/stick

DRUG

placebo plus paclitaxel

placebo: 50mg/10ml/stick Paclitaxel: 30mg/5ml/stick

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • ruihua Xu, Doctor · Sun Yat-sen University

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
2024-08-01
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • China

Study Locations

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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 NCT05978050 on ClinicalTrials.gov