drugset / Trial / NCT06030934

Study of The Second-line Treatment of Advanced Gastric / Gastroesophageal Junction Adenocarcinoma With Envafolimab and Lenvatinib Combined With Paclitaxel-albumin

NCT06030934

Phase 2 Unknown 30 enrolled Fudan University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is an open, exploratory clinical study. Eligible patients with advanced second-line gastric/gastroesophageal junction adenocarcinoma signed an informed consent form, were screened for enrollment, and were entered into Group A (non-immune retreatment group-patients who had failed previous first-line treatment with standard chemotherapy) and Group B (immune retreatment-patients who had obtained SD and above with best efficacy of previous first-line treatment with PD-1 antibody) based on whether they had received previous first-line treatment with PD-1 antibody. All patients received a combination of envafolimab and lenvatinib in combination with paclitaxel-albumin and were treated until disease progression, withdrawal of informed consent by the subject, loss to follow-up, and death, where treatment did not exceed 2 years. Clinical oncologic imaging assessments were performed using iRECIST every 8 weeks during treatment; safety assessments were performed using CTCAE 5.0, and adverse events were recorded throughout the study up to 30 days after the end of treatment.

Timeline

Start
2022-10-24
Primary completion
2024-11-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 200 mg Subcutaneous
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous