NCT06030934

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric / Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	envafolimab and lenvatinib combined with paclitaxel-albumin	envafolimab: 200mg d1,15 s.c. Q4W; lenvatinib: 8mg (\<60kg) or 12mg (≥60kg) p.o. Q.d.; paclitaxel-albumin: 100 mg/m2 d1,8,15 stop for one week, i.v. Q4W

Timeline

• Start date: 2022-10-24
• Primary completion: 2024-11-01
• Completion: 2025-09-01
• First posted: 2023-09-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: China