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

NCT07457528 | Recruiting Phase 2

• 1 other identifier: SINC-ESCC
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Resectable Esophageal Squamous Cell Carcinoma

Keywords

Serplulimab; Nimotuzumab; Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• MPR

  Major Pathological response

  3 months after the last subject participating in

Secondary Outcomes (1)

• pCR

  3 months after the last subject participating in

Other Outcomes (10)

• R0 resection rate

  3 months after the last subject participating in

• DFS

  up to 2 years

• EFS

  up to 2 years

Study Arms (1)

Serplulimab+Nimotuzumab+Chemoradiation

EXPERIMENTAL

Drug: HLX10; Drug: Chemotherapy; Drug: Nimotuzumab

Interventions

HLX10 DRUG

Serplulimab 300mg d1, d22

Also known as: Serplulimab

Serplulimab+Nimotuzumab+Chemoradiation

Chemotherapy DRUG

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

Serplulimab+Nimotuzumab+Chemoradiation

Nimotuzumab DRUG

Nimotuzumab 400mg d1, qw, total of 5 cycles

Serplulimab+Nimotuzumab+Chemoradiation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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%.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Drug Therapy; nimotuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Lei Gong, MD

CONTACT

13820389526; leigong@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

CN (1)