NCT06009705

Toripalimab Combined With Radiotherapy and S-1 for Older Patients With Esophageal Cancer

Efficacy and Safety of Toripalimab Combined With Radiotherapy and S-1 Followed by Adjuvant Toripalimab Maintenance Therapy for Older Patients With Esophageal Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 56 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer.

Detailed description

With the aging of the population, the number of elderly esophageal cancer patients is gradually increasing. For non-metastatic esophageal cancer patients, surgery is the first choice of treatment, but elderly esophageal cancer patients are often unable to tolerate surgical treatment due to more comorbidities and poor physical condition, etc. The results of previous studies have shown that the effect of radiotherapy treatment is also unsatisfactory, and the 5-year survival rate of esophageal cancer patients treated with radiotherapy is only 15-25%, which makes the clinical treatment of elderly patients even more difficult due to their poor physical tolerance. A multicentre randomised phase III clinical trial (NCT02813967) demonstrated that concurrent radiotherapy and S-1 treatment in elderly patients with esophageal cancer was tolerable and provided significant benefit compared with radiotherapy alone. In recent years, tumor immunotherapy has shown some efficacy in the field of cancer treatment by activating the body's own immune system to fight tumors. Therefore, this trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer. The primary study endpoints are objective remission rate (ORR), disease control rate (DCR), duration of remission (DOR) and safety. Secondary study endpoints are overall survival (OS) and progression-free survival (PFS).

Conditions

• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	toripalimab	JS001, the active ingredient of toripalimab injection, independently developed by Shanghai Junshi Biomedical Technology Co., Ltd, is an independently developed novel recombinant humanised (degree of 97%) anti-PD-1 monoclonal antibody (Chinese Patent License No. CN104250302B, PCT Patent Publication No. WO2014/206107A1), belonging to the human IgG4/Kappa subtype, and introducing a point mutation at the Serine to Proline (S228P) protein site 228 in the hinge region of the IgG4 heavy chain.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-04-30
• Completion: 2026-04-30
• First posted: 2023-08-24
• Last updated: 2023-08-24

Locations

1 site across 1 country: China