NCT06277024

A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients

Detailed description

Local advanced or metastatic HER2 negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology that cannot be resected, and has not received systemic treatment (including HER2 inhibitors) as the primary treatment for advanced or metastatic diseases in the past. Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients Median survival time (OS); * Progression free survival time (PFS); * Duration of relief (DOR); Evaluate the safety of this regimen in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma patients, including the incidence of adverse events (AE), severe adverse reactions (SAE), dose adjustment rate, and dose pause rate; Observe the changes in quality of life of patients with advanced gastric or gastroesophageal junction adenocarcinoma after treatment.

Conditions

• Overall Response Rate

Interventions

Type	Name	Description
DRUG	Combination of Cardonizumab with Lenvatinib and SOX regimen	Phase 1: Conduct a ramp up test on the dosage of lenvatinib according to the traditional 3+3 design; Phase 2: 6 cycles of treatment with candenizumab+lenvatinib+SOX regimen (Q3W); For patients who have not progressed, they will enter the third stage of maintenance treatment. Phase 3: Maintenance therapy with candenizumab, lenvatinib, and tigio (Q3W).

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2027-12-31
• First posted: 2024-02-26
• Last updated: 2024-02-26

Locations

1 site across 1 country: China