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

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.

Study Overview

• Status: Recruiting
• Conditions: Resectable Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: HLX10; Drug: Chemotherapy; Drug: Nimotuzumab

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lei Gong, MD; Phone Number: 13820389526; Email: leigong@tmu.edu.cn

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Lei Gong, MD; Phone Number: 13820389526; Email: leigong@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. Absolute neutrophil count ≥ 1.5×10^9, platelets ≥ 80×10^9, hemoglobin ≥ 90g/L;
  2. 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);
  3. Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula);
  4. Serum albumin ≥ 28g/L;
  5. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
  6. 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Serplulimab+Nimotuzumab+Chemoradiation	Drug: HLX10; Serplulimab 300mg d1, d22; Other Names: Serplulimab; Drug: Chemotherapy; Albumin-paclitaxel 175mg/m², carboplatin AUC = 4-5, d1, d22; Drug: Nimotuzumab; Nimotuzumab 400mg d1, qw, total of 5 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPR	Major Pathological response	3 months after the last subject participating in

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR	Pathological complete regression rate	3 months after the last subject participating in

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	up to 2 years
ORR	objective response rate	up to 2 years
R0 resection rate	R0 resection rate	3 months after the last subject participating in
DFS	disease-free survival	up to 2 years
EFS	event-free survival	up to 2 years
LEFS	local event-free survival	up to 2 years
DCR	disease control rate	up to 2 years
AE	adverse events	up to 2 years
SAE	serious adverse events	up to 2 years
QoL	We will use the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire score 30 (QLQ-C30) scale and the esophageal EORTC QLQ-OES18 scale to assess the quality of life of patients. The EORTC QLQ-C30 scale covers 5 functional dimensions , 9 symptom dimensions, and 1 global health status/quality of life (GHS/QoL) scale. The higher the scores of the functional dimensions and GHS/QoL, the better the quality of life. The higher the score in the symptom dimension, the heavier the symptom burden. EORTC QLQ-OES18 consists of 18 items, which are divided into the following core areas: dysphagia, eating disorders, reflux, pain and anxiety. The higher the score of the symptom dimension, the more severe the symptom. The higher the score of the function dimension, the better the function.	up to 2 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Esophageal Squamous Cell Carcinoma; Nimotuzumab; Serplulimab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Therapeutics; Drug Therapy; nimotuzumab
• Other Study ID Numbers: SINC-ESCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No