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Resectable Esophageal Squamous Cell CarcinomaPhase 2NCT07457528

Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC

A Phase 2 study testing HLX10, Chemotherapy and Nimotuzumab in people with Resectable Esophageal Squamous Cell Carcinoma, 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
Search all trials

Trial summary

This trial is conducted in patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 46 patients with resectable locally advanced esophageal cancer in Tianjin cancer hospital. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HLX10, Chemotherapy and Nimotuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
12 Mar 2026to 30 Jun 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign an informed consent form.
  • Age ≥ 18 years, ≤ 75 years, both genders are eligible.
  • Patients with histologically confirmed clinical stage of locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM staging).
  • ECOG: 0-1.
  • Expected to achieve R0 resection.
  • No prior treatment for the primary esophageal tumor, including drug therapy, surgery, and radiotherapy.
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  • No suspicious metastatic lymph nodes in the neck as suggested by neck enhanced CT or neck ultrasound; no systemic metastasis on imaging studies.
  • Measurable lesions according to RECIST 1.1 criteria.
  • Important organ functions meet the following requirements:
  • Absolute neutrophil count ≥ 1.5×10^9, platelets ≥ 80×10^9, hemoglobin ≥ 90g/L;
  • Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN (for patients with liver metastasis, AST and ALT levels ≤ 5 times ULN);
  • Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula);
  • Serum albumin ≥ 28g/L;
  • Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
  • Pulmonary function: FEV1/FVC ≥ 70%, FEV1 ≥ 50% of normal value, DLCO (diffusing capacity of the lung for carbon monoxide) measured value to predicted value percentage > 80%.
  • Women of childbearing age must agree to use contraception (such as intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the study ends; negative serum or urine pregnancy test within 7 days before study enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the study ends.
  • Must understand and sign the informed consent form.

Who cannot join

  • Within the past six months, received EGFR monoclonal antibodies or EGFR-TKIs.
  • Participated in other interventional clinical trials within 30 days prior to screening.
  • Have severe comorbidities, such as heart failure, high-risk uncontrollable arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD stage 4 or higher), thyroid dysfunction, mental disorders, diabetes, severe chronic diarrhea (more than 7 bowel movements per day), etc., and those deemed unsuitable for this clinical study by the investigator.
  • Patients with brain metastases with symptoms or symptom control for less than 3 months.
  • History of other malignancies (except for cured in situ cervical cancer or skin basal cell carcinoma, and other malignancies cured for more than 5 years).
  • Presence of active infection or active infectious disease.
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  • Multifocal esophageal malignant tumors or presence of esophageal fistula or perforation signs.
  • Imaging shows tumor invasion of important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the subsequent study period, leading to fatal major bleeding.
  • Allergy to the drugs used in this protocol or their components.
  • According to the Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0), peripheral neuropathy or hearing loss of grade ≥2.
  • Pregnant or breastfeeding women.
  • Those with a history of psychiatric drug abuse and unable to quit, or patients with mental disorders.
  • Those deemed unsuitable for this study by the investigator.
  • Those unwilling to participate in this study or unable to sign the informed consent form.

Trial locations and contacts

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

Lei Gong, MD contact

13820389526

leigong@tmu.edu.cn

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

    Lei Gong, MD, 13820389526, leigong@tmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

This trial is conducted in patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 46 patients with resectable locally advanced esophageal cancer in Tianjin cancer hospital. Patients will be treated with serplulimab, nimotuzumab plus concurrent chemoradiotherapy (41.4Gy/1.8Gy/23F) . Six to eight weeks after the completion of neoadjuvant chemoradiotherapy, patients who are considered operable by surgeons will undergo radical resection of esophageal cancer. Postoperative pathological assessment includes MPR rate, pCR rate, and pathological response grade, etc. This trial aims to explore the safety and efficacy of adding serplulimab and nimotuzumab to neoadjuvant chemoradiotherapy, with a focus on whether the combined treatment regimen can enhance the efficacy and safety of neoadjuvant chemoradiotherapy.

Being tested
HLX10, Chemotherapy, Nimotuzumab
Keywords
Serplulimab, Nimotuzumab, Esophageal Squamous Cell Carcinoma
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • HLX10Drug

    Also called Serplulimab

    Serplulimab 300mg d1, d22

  • ChemotherapyDrug

    Albumin-paclitaxel 175mg/m², carboplatin AUC = 4-5, d1, d22

  • NimotuzumabDrug

    Nimotuzumab 400mg d1, qw, total of 5 cycles

Study groups in NCT07457528
Study groupRoleWhat they receive
Serplulimab+Nimotuzumab+ChemoradiationExperimentalNot described
Receives: Drug: HLX10; Drug: Chemotherapy; Drug: Nimotuzumab

What is being measured

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

  1. MPR

    Major Pathological response

    Measured: 3 months after the last subject participating in

Secondary outcomes (1)

  1. pCR

    Pathological complete regression rate

    Measured: 3 months after the last subject participating in

Timeline

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

  1. First posted9 Mar 2026
  2. Study start12 Mar 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 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
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457528
Sponsor's protocol ID
SINC-ESCC
Status last verified
Mar 2026
First submitted
3 Mar 2026
Last updated
11 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HLX10, Chemotherapy and Nimotuzumab in people with Resectable Esophageal Squamous Cell Carcinoma, 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 17 inclusion and 14 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 11 Mar 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 Lei Gong, MD (13820389526, leigong@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MPR (time frame: 3 months after the last subject participating in). 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 NCT07457528.

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 11 Mar 2026.

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