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This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant PD-1 Blockade Plus Chemotherapy | Experimental | PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cyclesï¼› Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cyclesï¼› Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 blockade | Drug | PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete remission (PCR) | Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell. | 4 weeks after surgery |
| Major Pathologic Response (MPR) | MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Li, MD | Contact | 13701288153 | qinli128003@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qin li | Recruiting | Beijing | Beijing Municipality | 100029 | China |
There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D016190 | Carboplatin |
| C053989 | nedaplatin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| Albumin paclitaxel | Drug | Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles. |
|
| Carboplatin/Nedaplatin | Drug | Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles. |
|
| 4 weeks after surgery |
| Overall survival (OS) | Overall survival was defined as the time from randomization grouping to the time of death due to any cause. | 24 months |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |