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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC

Concurrent Chemoradiation Plus Iparomlimab Consolidation Therapy for Older Patients With Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-arm Phase II Clinical Study

Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC (NCT07038629) is a Phase 2 interventional studying Esophageal Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 52 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Esophageal Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Volunteered to participate, cooperated with follow-up visits; 2. Aged ≥ 70 years, both male and female; 3. diagnosed by tissue sample (biopsy-confirmed) cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC ); 4. Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition); 5. Initial treatment: definitive concurrent chemoradiotherapy (radiotherapy: total dose 50.4 Gy, delivered in 28 fractions, 1.8 Gy per fraction, 5 times per week; chemotherapy: S-1: 40-60mg, BID, d1-14, d22-35, for a total of 2 cycles). 1. Radiotherapy: completed ≥ 25 fractions or more (i.e., radiotherapy dose ≥ 45 Gy), S-1chemotherapy: completed at least one cycle (d1-14); 2. 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); 6. You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1; 7. Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \[FFPE\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections; 8. Expected survival of ≥ 3 months. 9. The function of major organs meets the following requirements: 1. Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; 2. platelet count at least 100×10\^9/L; 3. blood count (hemoglobin) at least 9g/dL; 4. Serum albumin ≥ 2.8g/dL; 5. Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN; 6. Serum creatinine ≤ 1.5 × ULN or kidney function (creatinine clearance) at least 60mL/min; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Volunteered to participate, cooperated with follow-up visits; 2. Aged ≥ 70 years, both male and female; 3. Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC ); 4. Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition); 5. Initial treatment: definitive concurrent chemoradiotherapy (radiotherapy: total dose 50.4 Gy, delivered in 28 fractions, 1.8 Gy per fraction, 5 times per week; chemotherapy: S-1: 40-60mg, BID, d1-14, d22-35, for a total of 2 cycles). 1. Radiotherapy: completed ≥ 25 fractions or more (i.e., radiotherapy dose ≥ 45 Gy), S-1chemotherapy: completed at least one cycle (d1-14); 2. 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); 6. ECOG performance status 0 or 1; 7. Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \[FFPE\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections; 8. Expected survival of ≥ 3 months. 9. The function of major organs meets the following requirements: 1. Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; 2. Platelets ≥ 100×10\^9/L; 3. Hemoglobin ≥ 9g/dL; 4. Serum albumin ≥ 2.8g/dL; 5. Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN; 6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min; 7. 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); 10. Documented informed consent. Exclusion Criteria: 1. Surgery for esophageal cancer; 2. Esophageal fistulae due to infiltration of the primary tumor; 3. Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation; 4. Patients who developed ≥ grade 2 pneumonia after concurrent chemoradiotherapy with S-1; 5. Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention; 6. Major surgery or severe trauma within 4 weeks prior to first use of study drug; 7. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage; 8. Received or receiving any of the following treatments in the past: 1. Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy; 2. Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment; 3. 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(except for the use of corticosteroids for local inflammation of the esophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor. 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; 4. Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment; 9. Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included; 10. Diagnosis of immunodeficiency, including positive HIV test, other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation; 11. Diagnosis of uncontrolled cardiac clinical symptoms or disease such as: a. NYHA II or above heart failure; b. unstable angina; c. myocardial infarction within 1 year; d. clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 12. Severe infections (CTCAE \> grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use; 13. History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests; 14. Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment; 15. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection); 16. Presence of abnormal sodium, potassium, and calcium laboratory test values greater than grade 1 within 2 weeks prior to randomisation that do not improve with treatment; 17. Known hypersensitivity to large protein preparations, or to any of the components of tirilizumab, or anaphylaxis, hypersensitivity, or contraindication to paclitaxel or cisplatin or to any of the components used within their preparations; 18. Previously diagnosed with any other malignancy before the first use of the investigational drug, except for malignancies with low risk of metastasis and death (5-year survival rate\>90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ. 19. As judged by the investigator, the subject has other factors that may lead to forced termination of the study midway.

Treatments Being Tested

DRUG

S1

PO, 40\~60mg,BID(d1-14,d22-35,two cycles)

DRUG

Iparomlimab

IV infusion, 5mg/kg, q3w (Started within 8 weeks of completion of radiation)

RADIATION

Radiation

Concurrent Radiation, 1.8Gy/f, 28f;

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07038629), the sponsor (Tianjin Medical University Cancer Institute and Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07038629 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07038629?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07038629?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07038629. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07038629. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.