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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
This study is a prospective, randomized controlled, open label clinical trial aimed at evaluating the efficacy and safety of the combination of nimotuzumab,camrelizumab, and neoadjuvant chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma. The enrolled patients will receive neoadjuvant therapy (camrelizumab ±nimotuzumab+Albumin Paclitaxel+Cisplatin) and esophageal cancer radical surgery (performed within 4 weeks after the last drug treatment). This study includes screening period, treatment period, efficacy follow-up period, and survival follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy(nCT) | Experimental | Experimental group:
|
|
| Camrelizumab+Neoadjuvant chemotherapy(nCT) | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab 400mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) rate | Pathological complete response (pCR) rate | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Zhihao MM Lu, PHD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of GI Oncology, Peking University Cancer Hospital, | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| C000631724 | camrelizumab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| camrelizumab |
| Drug |
camrelizumab 200mg |
|
| Albumin paclitaxel | Drug | Albumin paclitaxel 125mg/m2 |
|
| Cisplatin | Drug | Cisplatin 75mg/m2 |
|
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |