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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.
This study aimed to evaluate the efficacy and safety of adding immunotherapy to neoadjuvant chemotherapy (CT) or chemoradiotherapy (CRT) compared to neoadjuvant CRT alone for resectable locally advanced esophageal squamous cell carcinoma (ESCC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemotherapy With Camrelizumab | Experimental | Chemotherapy: Paclitaxel(Albumin Bound)100mg/m2, Day 1,8,15,Carboplatin AUC=5mg/ml/min, Day 1; Camrelizumab: Day 1, every 3 weeks, 2 cycles; Postoperative adjuvant treatment: Camrelizumab maintenance |
|
| Neoadjuvant Radiochemotherapy With Camrelizumab | Experimental | Chemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29,Carboplatin AUC=2mg/ml/min,Day 1,8,15,22,29 Camrelizumab: 200mg,Day 1,22 Radiotherapy: 41.4 Gy , D1-5/W Postoperative adjuvant treatment:Camrelizumab maintenance |
|
| Neoadjuvant Radiochemotherapy | Active Comparator | Chemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29,Carboplatin AUC=2mg/ml/min,Day 1,8,15,22,29 Radiotherapy:41.4 Gy , D1-5/W. Postoperative adjuvant treatment: non-pCR: Camrelizumab maintenance; PCR: surveillance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| EFS assessed by the investigator according to RECIST 1.1 | defined as event free survival,defined as the time from randomization to the occurrence of tumor progression/recurrence /death, whichever comes first | median EFS approximately over 45 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | defined as the time from registration to death due to any cause, or censored at date last known alive | median OS approximately over 80 months |
| R0 resection rate | defined as complete surgery resection rate |
| Measure | Description | Time Frame |
|---|---|---|
| biomarker testing | explore the correlation between the expression of PD-L1 and outcomes | approximately 48 months |
Inclusion Criteria:
Exclusion Criteria:
There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery;
Patients with supraclavicular lymph node metastasis;
Poor nutritional status, BMI <18.5 Kg/m2; if the symptomatic nutritional support is corrected before randomization, the main investigator can continue to consider it after evaluation;
Those who are known to have a history of allergies to the drug components of this program;
Have received or are receiving any of the following treatments in the past:
A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
There are clinical symptoms or diseases of the heart that are not well controlled;
Severe infections (CTCAE v5.0> level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest activity Pulmonary inflammation, symptoms and signs of infection in the 14 days before the first use of the study drug, or those who require oral or intravenous antibiotic treatment, except for the prophylactic use of antibiotics;
Participated in other drug clinical studies within 4 weeks before randomization;
People who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy, or have other pulmonary fibrosis that may interfere with the judgment and management of immune-related lung toxicity , Organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects whose CT shows active pneumonia or severe lung dysfunction during the screening period; active tuberculosis;
Patients with any active autoimmune diseases or history of autoimmune diseases with the possibility of recurrence; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, and insulin treatment Patients with controllable type I diabetes or a history of asthma, but who have been completely relieved during childhood without any intervention can be included in the group; patients with asthma who need bronchodilator intervention cannot be included in the group;
There is active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analytical method);
Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, unless malignant tumors with low risk of metastasis or death (5-year survival rate> 90%), such as fully treated skin basal cell carcinoma or squamous cell Skin cancer or cervical carcinoma in situ, etc., may be considered for inclusion;
Women who are pregnant or breastfeeding;
According to the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as suffering from other serious diseases (including mental illness) requiring combined treatment, alcoholism, drug abuse, family or social factors, which may affect the subjects Factors of safety or compliance.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Yang | Contact | 18930598090 | yangyang321879@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Yang | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35524205 | Derived | Yang Y, Zhu L, Cheng Y, Liu Z, Cai X, Shao J, Zhang M, Liu J, Sun Y, Li Y, Yi J, Yu B, Jiang H, Chen H, Yang H, Tan L, Li Z. Three-arm phase II trial comparing camrelizumab plus chemotherapy versus camrelizumab plus chemoradiation versus chemoradiation as preoperative treatment for locally advanced esophageal squamous cell carcinoma (NICE-2 Study). BMC Cancer. 2022 May 6;22(1):506. doi: 10.1186/s12885-022-09573-6. |
| Label | URL |
|---|---|
| ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies (相关术语定义) | View source |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| radiotherapy | Radiation | The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy. |
|
| within 28 working days after surgery |
| DFS | defined as the time from the date of surgery who completed R0 resection to local or distant recurrence, or death due to any cause, whichever occurs first; | median DFS approximately over 40 months |
| HRQoL | defined as quality and nutrition assessment | approximately 48 months |
| pCR | pCR is defined as pathological complete response(ypT0/TisN0) | within 28 working days after surgery |
| MPR | MPR is defined as the percentage of subjects with <10% residual tumor in the primary tumor site | within 28 working days after surgery |
| Adverse events (AEs) | Incidence and grade (including serious adverse events [SAEs] and immune-related adverse events [irAEs]), determined according to the NCI-CTCAE 5.0 criteria | through study completion, assessed up to 50 months |
| Anyang Tumour Hospital | Recruiting | Anyang | China |
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| Sun yat-sen University Cancer Center | Recruiting | Guangzhou | China |
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| Anhui Provincial Hospital | Recruiting | Hefei | China |
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| Zhongshan Hospital of Fudan University | Recruiting | Shanghai | China |
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| Checklists, templates, and examples to help gather information needed to report results to ClinicalTrials.gov (试验结果填写指南) | View source |