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In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with chemoradiotherapy. The primary endpoint is 2-year overall survival rate in this watch-and-wait cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| perioperative treatment with adebrelimab and CRT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab and nab-paclitaxel and carboplatin | Drug | Adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year OS rate | An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| cCR rate | A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions. | 12 months |
| median EFS | An event-free survival (EFS) is defined as the duration from the start of treatment until disease recurrence or death from any cause, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects have received or are receiving any of:
Cancer-related exclusion criteria
Other criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhigang Li, MD, PhD | Contact | 86-18960619260 | zhigang.li@shsmu.edu.com | |
| Zhichao Liu, MD, PhD | Contact | 86-15622175948 | zhichao.liu@sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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| Radiation | Radiation | concurrent chemoradiotherapy |
|
| standard oesophagectomy | Procedure | standard oesophagectomy |
|
| active surveillance | Other | active surveillance |
|
| 24 months |
| median OS | An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence. | 24 months |
| Incidence, type and severity of adverse events as assessed by CTCAE 5.0 | Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 adverse events and higher-grade will be reported. | 24 months |
| quality of life (QOL) | Evaluate quality of life using EORTC QLQ-C30 | 24 months |
| quality of life (QOL) assessed by EORTC QLQ-OES18 | Evaluate quality of life using EORTC QLQ-OES18 | 24 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 |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| D011827 | Radiation |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D055585 | Physical Phenomena |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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