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Esophageal CancerPhase 2NCT07038629

Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC

A Phase 2 study testing S1, Iparomlimab and Radiation in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 to 90 years
Conditions the study is for
Esophageal Cancer
What is being tested?
S1, Iparomlimab and Radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
8 Sep 2025to 30 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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);
  • 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).
  • Radiotherapy: completed ≥ 25 fractions or more (i.e., radiotherapy dose ≥ 45 Gy), S-1chemotherapy: completed at least one cycle (d1-14);
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  • 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);
  • ECOG performance status 0 or 1;
  • 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;
  • Expected survival of ≥ 3 months.
  • 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);
  • Documented informed consent.

Who cannot join

  • 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;
  • Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
  • Major surgery or severe trauma within 4 weeks prior to first use of study drug;
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  • Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
  • Received or receiving any of the following treatments in the past:
  • Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;
  • Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
  • 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;
  • Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;
  • 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;
  • Diagnosis of immunodeficiency, including positive HIV test, other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
  • 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;
  • 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;
  • History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;
  • 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;
  • 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);
  • 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;
  • 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;
  • 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.
  • As judged by the investigator, the subject has other factors that may lead to forced termination of the study midway.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wencheng Zhang, M.D. contact

02223340123 ext. 1121

zhangwencheng@tjmuch.com

Linrui Gao, M.D. contact

02223340123 ext. 1121

China1 site, 1 recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

    Wencheng Zhang, M.D., 02223340123 ext. 1121, zhangwencheng@tjmuch.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
S1, Iparomlimab, Radiation
Keywords
Old Age, Esophageal Cancer, Iparomlimab, Chemoradiation
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S1Drug

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

  • IparomlimabDrug

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

  • RadiationRadiation

    Concurrent Radiation, 1.8Gy/f, 28f;

Study groups in NCT07038629
Study groupRoleWhat they receive
Chemoradiation Plus Iparomlimab ConsolidationExperimentalS1 + Radiotherapy+ Iparomlimab Consolidation: Chemotherapy: S1 PO, 40~60mg，BID（d1-14，d22-35，two cycles); Radiation: Concurrent Radiation, 1.8Gy/f, 28f; Iparomlimab Consolidation: Iparomlimab IV infusion, 5mg/kg, q3w (Started within 8 weeks of completion of radiation)
Receives: Drug: S1; Drug: Iparomlimab; Radiation: Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    progression-free survival

    Measured: up to 2 years

Secondary outcomes (6)

  1. OS

    overall survival

    Measured: up to 2 years

  2. ORR

    overall response rate

    Measured: up to 2 years

  3. DoR

    Duration of Response

    Measured: up to 2 years

  4. AEs

    Adverse Events

    Measured: up to 2 years

  5. QoL

    Quality of Life (QoL) score

    Measured: up to 2 years

  6. CGA

    Comprehensive Geriatric Assessment

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start8 Sep 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07038629
Sponsor's protocol ID
E20250418
Status last verified
May 2026
First submitted
21 May 2025
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S1, Iparomlimab and Radiation in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wencheng Zhang, M.D. (02223340123 ext. 1121, zhangwencheng@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07038629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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