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NICE-RT study is a "safety run-in" and phase II trial evaluating the safety and efficacy of Camrelizumab combined with Nab-paclitaxel and Carboplatin and Radiotherapy in patients with resectable locally advanced esophageal squamous cell carcinoma.
Considering that immunotherapy combined with concurrent chemoradiotherapy may have unknown AEs, in order to explore the safety and tolerability of the regimen of camrelizumab combined with nab-paclitaxel and carboplatin and radiotherapy, this study set up an initial "safety run-in" phase. 10 patients will be firstly enrolled, and treatment-related adverse reactions(TRAEs)and surgical complications will be observed at the same time. If the completion rate of neoadjuvant therapy and surgery is greater than 80%, rate of 30-day major complication is less than 20%,and no death, it will continue to enroll 40 patients to explore the efficacy and safety of the regimen. If the completion rate of neoadjuvant therapy and surgery is less than 80%, the MDT will determine whether the study move forward. If treatment related death is more than 1 patients, the study will be terminated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy combined with Chemoradiotherapy | Experimental | A:Chemotherapy: nab-paclitaxel (80mg/m2), carboplatin (AUC=2),on day 1,8,15,22,29; B:Immunotherapy: camrelizumab (200mg),IV on days 5 and 26; C:Radiotherapy: Primary lesion and adjacent lymph nodes: 41.4Gy, 1.8Gy/23f; Abscopal lymph node 2Gy, 0.5Gy/4f. D:Ivor-Lewis or McKeown esophagectomy The participants will receive preoperative A+B+C. 4-6 weeks after completion of preoperative therapy ,D will be performed if there is no contraindication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy (nab-paclitaxel AUC=2 and carboplatin 80mg/m2),Immunotherapy (camrelizumab 200mg)、Radiotherapy(primary lesion and adjacent lymph nodes 41.4Gy, distant lymph node 0.5Gy*4) | Drug |
Camrelizumab: (200mg, Q3W),continued for up to 1 years,until PD or intolerable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety(The rates of grade 3 and higher-grade treatment-related adverse events) | Incidence of adverse events using CTCAE 4.03;grade 3 treatment-related adverse events and higher-grade adverse event will be reported | From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose |
| pCR | pathological complete response (pCR) is defined as disappearance of all invasive cancer after completion of neoadjuvant chemotherapy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MPR | major pathologic response (MPR) is defined as residual viable tumor of less than or equal to 10% | 12 months |
| ORR | objective response rate (ORR) is defined as the proportion of patients with a complete response(CR) or partial response(PR) to treatment according to RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
1.Pathological type and stage
2. Medical history and complications
3. Laboratory inspection
4. Allergies and adverse drug reactions should be excluded
5. Diseases or abnormal laboratory indicators that the investigator believes will affect the research results or are not in line with the interests of the subject should be excluded.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Liu, M.D. | Contact | +862122200000 | 3602 | drjunliu@qq.com |
| Xiaolong Fu, M.D. | Contact | +862122200000 | 3602 |
| Name | Affiliation | Role |
|---|---|---|
| Jun Liu, M.D. | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
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|
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| 12 months |
| EFS | event-free survival (EFS) is defined as the time after treatment that a group of people in a clinical trial has not had cancer come back or get worse | 12 months |
| OS | overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence | 12 months |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D016190 | Carboplatin |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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