Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy（nCT） in the Treatment of Esophageal Squamous Cell Carcinoma

NCT07312578 | Enrolling By Invitation Phase 2

• 1 other identifier: IST-Nim-ESCC-26
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

We plan to conduct a single-center,prospective, Open Label, Randomized Controlled, Phase II Clinical Study of the Combination of Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Nimotuzumab

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  Pathological complete response (pCR) rate

  up to 2 years

Secondary Outcomes (1)

• Event-free survival （EFS）

  from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years

Study Arms (2)

Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

EXPERIMENTAL

Experimental group: 1. Nimotuzumab: 400mg, Intravenous（iv）, day1（D1）, quaque week（QW）, 6 cycles; 2. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles; 3. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles; 4. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Drug: Nimotuzumab; Drug: camrelizumab; Drug: Albumin paclitaxel; Drug: Cisplatin

Camrelizumab+Neoadjuvant chemotherapy（nCT）

ACTIVE COMPARATOR

1. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles; 2. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles; 3. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Drug: camrelizumab; Drug: Albumin paclitaxel; Drug: Cisplatin

Interventions

Nimotuzumab DRUG

Nimotuzumab 400mg

Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

camrelizumab DRUG

camrelizumab 200mg

Camrelizumab+Neoadjuvant chemotherapy（nCT）; Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

Albumin paclitaxel DRUG

Albumin paclitaxel 125mg/m2

Camrelizumab+Neoadjuvant chemotherapy（nCT）; Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

Cisplatin DRUG

Cisplatin 75mg/m2

Camrelizumab+Neoadjuvant chemotherapy（nCT）; Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Sign the informed consent form; 2. Age range: 18-70 years old, both male and female are acceptable; 3. Esophageal squamous cell carcinoma patients diagnosed by histology or cytology; 4.ECOG：0～1； 5. Expected survival period ≥ 12 weeks; 6. Have not received any treatment for primary esophageal tumors in the past, including drug therapy, surgical treatment, and radiation therapy, etc; 7. Clinical staging: cT1-4a, N1-3, M0 (AJCC/UICC esophageal cancer staging (8th edition)), can be surgically resected; 8. Important organ functions meet the following requirements:
• Absolute neutrophil count ≥ 1.5 × 109, platelet count ≥ 80 × 109, hemoglobin count ≥ 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 metastases, 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 evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
• Pulmonary function: FEV1/FVC ≥ 70%, FEV1 ≥ 50% normal value, percentage of measured and predicted DLCO (lung diffusion function)\>80%.
• \. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test must be negative and the patient must be non lactating; Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.

You may not qualify if:

• \. Patients with any active autoimmune diseases or autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 2. The patient is currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose\>10mg/day of prednisone or other therapeutic hormones), and has continued to use them within the 2 weeks prior to enrollment; 3. Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors; 4. Patients with any severe and/or uncontrolled illnesses, including:
• Patients with poor blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100 mmHg); Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I cardiac dysfunction;
• Active or uncontrolled severe infections;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Department of GI Oncology, Peking University Cancer Hospital,

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

nimotuzumab; camrelizumab; Cisplatin

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Zhihao MM Lu, PHD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Digestive Oncology

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)