OncoMatch/Clinical Trials/NCT07038629
Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC
Is NCT07038629 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including S1 and Iparomlimab for esophageal cancer.
Treatment: S1 · Iparomlimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Disease stage
Required: Stage CT1N2-3M0, CT2-4BN0-3M0, CT1-4BN0-3M1 (SUPRACLAVICULAR LYMPH NODE METASTASIS) (8th AJCC)
Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC )
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: radiation therapy — definitive concurrent chemoradiotherapy
Radiotherapy: completed ≥ 25 fractions or more (i.e., radiotherapy dose ≥ 45 Gy)
Must have received: cytotoxic chemotherapy (S-1) — definitive concurrent chemoradiotherapy
S-1chemotherapy: completed at least one cycle (d1-14)
Cannot have received: systemic anti-tumor therapy
Exception: before radiotherapy
Haven't received any previous systemic anti-tumor therapy before radiotherapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational treatment drugs)
Cannot have received: anti-PD-1 therapy
Anti-PD-1 or anti-PD-L1 antibody therapy
Cannot have received: anti-PD-L1 therapy
Anti-PD-1 or anti-PD-L1 antibody therapy
Cannot have received: chemotherapy
chemotherapy
Cannot have received: radiation therapy
radiotherapy
Cannot have received: targeted therapy
targeted therapy
Cannot have received: investigational agent
Exception: within 4 weeks before the first dose of study treatment
Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment
Cannot have received: systemic corticosteroids
Exception: except for the use of corticosteroids for local inflammation of the esophagus and for the prevention of allergy and nausea and vomiting; inhaled or topical steroids and adrenocorticotropic hormone replacement at doses >10mg/day prednisone efficacy dose are permitted if the patient does not have active autoimmune disease
Systemic treatment with corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment
Cannot have received: anti-tumour vaccine
Exception: within 4 weeks before the first dose of study treatment
Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥ 9g/dL
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN
The function of major organs meets the following requirements: Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥ 9g/dL; Serum albumin ≥ 2.8g/dL; Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min; International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (subjects on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and with INR within the expected therapeutic range of the anticoagulant can be screened)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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