Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy（nCT） in the Treatment of Esophageal Squamous Cell Carcinoma
A 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Department of GI Oncology, Peking University Cancer Hospital,
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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%.
9. 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.
Exclusion Criteria:
1. 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;
- Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method); 5. Patients whose imaging shows that the tumor has invaded important blood vessels or whose researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal bleeding during subsequent studies; 6. Pregnant or lactating women; Patients with other malignant tumors within 7.5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 8. Patients with a history of abuse of psychotropic drugs who cannot be quit or those with mental disorders; 9. Patients who have participated in clinical trials of other drugs within the past four weeks; 10. Patients with accompanying diseases that pose a serious threat to patient safety or affect the completion of the study, as determined by the researchers; 11.Researchers believe that it is not suitable for inclusion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）
Experimental group:
|
Nimotuzumab 400mg
camrelizumab 200mg
Albumin paclitaxel 125mg/m2
Cisplatin 75mg/m2
|
|
Active Comparator: Camrelizumab+Neoadjuvant chemotherapy（nCT）
|
camrelizumab 200mg
Albumin paclitaxel 125mg/m2
Cisplatin 75mg/m2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pathological complete response (pCR) rate
Time Frame: up to 2 years
|
Pathological complete response (pCR) rate
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event-free survival （EFS）
Time Frame: from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years
|
Event-free survival (assessed by the investigator per RECIST v1.1 criteria)
|
from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhihao MM Lu, PHD, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- Inorganic Chemicals
- Chlorine Compounds
- Nitrogen Compounds
- Platinum Compounds
- Cisplatin
- camrelizumab
- nimotuzumab
Other Study ID Numbers
- IST-Nim-ESCC-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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