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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
S1
DrugPO, 40\~60mg,BID(d1-14,d22-35,two cycles)
Iparomlimab
DrugIV infusion, 5mg/kg, q3w (Started within 8 weeks of completion of radiation)
Radiation
RadiationConcurrent Radiation, 1.8Gy/f, 28f;
Treatment groups
Trial outcomes
Primary outcomes
PFS
progression-free survival
Secondary outcomes
OS
overall survival
ORR
overall response rate
DoR
Duration of Response
AEs
Adverse Events
Sponsors and contacts
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Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Shanxi Province Cancer Hospital
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator