Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70-90
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma (ESCC). Aim to evaluate the efficacy and safety of Iparomlimab consolidation therapy following concurrent chemoradiation with S-1 in elderly patients with unresectable locally advanced ESCC.

Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. However, the overall prognosis of patients still needs to be further improved. The emergence of immune checkpoint inhibitors has brought new hope for patients with ESCC. Iparomlimab can target both PD-1 and CTLA-4 immune inhibitory pathways simultaneously. Studies have shown that it can significantly improve the prognosis in the treatment of ESCC and has good tolerability. In elderly patients with ESCC, concurrent chemoradiation may potentially carry the risk of low treatment completion rate and significant toxicity. Therefore, this study aims to explore the efficacy and safety of Iparomlimab consolidation therapy following concurrent chemoradiotherapy in elderly patients with unresectable locally advanced ESCC.

In the study, the investigators plan to enroll 52 elderly subjects with locally advanced ESCC. After receiving radiotherapy combined with the S-1 regimen, patients will enter the screening period. The enrolled patients will receive Iparomlimab consolidation therapy for 1 year. The treatment efficacy and safety will be evaluated.

Eligibility criteria

Qualifiers

Volunteered to participate, cooperated with follow-up visits;

Aged ≥ 70 years, both male and female;

Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC );

Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);

Disqualifiers

Surgery for esophageal cancer;

Esophageal fistulae due to infiltration of the primary tumor;

Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;

Patients who developed ≥ grade 2 pneumonia after concurrent chemoradiotherapy with S-1;

Trial design

Treatments tested in this trial

  • S1
  • Iparomlimab
  • Radiation

Treatment groups

52 Participants
are divided into 1 treatment group

Sponsors and collaborators

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Shanxi Province Cancer Hospital

Collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator