NCT06354218

Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

A Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study of Serplulimab Combined With Synchronous Radiochemotherapy for the Treatment of Locally Advanced Esophageal Squamous Cell Cancer in Elderly Patients With Non Surgical Resectable Lesions Research Plan

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study to evaluate the effectiveness of the combination of Serplulimab and Concurrent Chemoradiotherapy in the treatment of elderly patients with locally advanced esophageal cancer who cannot be treated surgically.Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.

Detailed description

It is expected that 50 patients will be enrolled, and patients who meet the enrollment criteria will undergo esophagoscopy, esophageal barium meal examination, chest contrast-enhanced CT, abdominal ultrasound, electrocardiogram, blood routine, whole body bone scan, liver and kidney function and other examinations before treatment, and esophageal ultrasound if necessary. Patients who received esophageal ultrasound were staged by esophageal ultrasound results, and those without esophageal ultrasound were mainly staged according to the cervical chest and epigastric contrast CT and esophageal barium plates, and clinical staging was performed according to the AJCC staging standard. After the combination of Serplulimab and concurrent chemoradiotherapy, adverse reactions and efficacy evaluation were observed. The expected result is that the local control rate of Serplulimab combined with chemoradiotherapy is improved in patients with locally advanced elderly esophageal squamous cell carcinoma, and there is no significant increase in adverse reactions, and serological indicators such as PDL-1 CPS can be used as prognostic indicators for esophageal malignancy and have certain guiding significance for treatment. PD-1 monoclonal antibody can be used in locally advanced elderly esophageal cancer patients who cannot tolerate chemotherapy, with good short-term efficacy and tolerable toxic side effects, which further provides reference value for clinical guidance.

Conditions

• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Serplulimab	Serplulimab （4.5mg/Kg every 3 weeks）

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2024-04-09
• Last updated: 2024-04-09

Locations

1 site across 1 country: China