Actively Recruiting
Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-01-07
52
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
S
Shanxi Province Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and cooperate with follow-up visits
- Aged 70 years or older, any gender
- Histologically confirmed locally advanced esophageal squamous cell carcinoma as defined by specific staging criteria
- Presence of measurable or non-measurable lesions
- Completed definitive concurrent chemoradiotherapy including at least 25 fractions of radiotherapy and at least one cycle of S-1 chemotherapy
- No prior systemic anti-tumor therapy before radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Able to provide fresh or archived tumor tissue samples within 6 months for biomarker analysis
- Expected survival of at least 3 months
- Adequate major organ function based on defined blood counts, liver and kidney function tests, and coagulation parameters
- Provided documented informed consent
You will not qualify if you...
- Prior surgery for esophageal cancer
- Presence of esophageal fistula due to tumor infiltration
- Risk of gastrointestinal bleeding, esophageal fistula, or perforation
- Grade 2 or higher pneumonia after concurrent chemoradiotherapy with S-1
- Poor nutritional status with significant recent weight loss not improved by intervention
- Major surgery or severe trauma within 4 weeks before starting study drug
- Uncontrollable pleural, pericardial effusion, or ascites requiring repeated drainage
- Previous or current anti-PD-1/PD-L1 therapy, chemotherapy, radiotherapy, or targeted therapy prior to study treatment
- Participation in investigational drug/device study within 4 weeks before first dose
- Systemic corticosteroid or immunosuppressive treatment exceeding defined limits before study treatment
- Recent receipt of anti-tumor or live vaccines within 4 weeks prior to study treatment
- Active autoimmune diseases or history except certain stable conditions
- Immunodeficiency including HIV, organ or bone marrow transplantation
- Uncontrolled cardiac diseases or symptoms
- Severe infections within 4 weeks prior to study treatment
- History of interstitial lung disease or severe pulmonary insufficiency
- Active or recent tuberculosis infection
- Active hepatitis B or C infection
- Significant electrolyte abnormalities not improved with treatment
- Known hypersensitivity to study drugs or components
- Previous malignancies except certain low-risk cancers
- Other factors judged by investigators that may cause early study termination
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
W
Wencheng Zhang, M.D.
CONTACT
L
Linrui Gao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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