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Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant immunochemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant immunochemotherapy +/- short-term radiotherapy | Experimental | Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-albumin | Drug | 260mg/m2, ivdrip, d1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response rate | The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery | Three to five working days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | iRECIST criteria defined complete response and partial response | Up to 24 weeks |
| Safety as measured by number of participants with Grade 3 and 4 adverse events | Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guibin Qiao, MD | Contact | 13602749153 | guibinqiao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Guibin Qiao, MD | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39144362 | Derived | Huang S, Yu H, Li Z, Tang Y, Luo L, Wu J, Li X, Shi Q, Xie S, Qiao G. Electronic patient-reported outcome-based surveillance system to evaluate safety and efficacy of preoperative immunochemotherapy with or without short-term chemoradiation in patients with esophageal squamous cell carcinoma (ePRO-PICCRT): protocol for a prospective, single-arm, phase II study. J Thorac Dis. 2024 Jul 30;16(7):4719-4726. doi: 10.21037/jtd-24-274. Epub 2024 Jul 8. |
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| Cisplatin | Drug | 60mg/m2, ivdrip, d1 |
|
| Carboplatin | Drug | AUC=4-6, ivdrip, d1 |
|
| Tislelizumab | Drug | 200mg, ivdrip, d1 |
|
| VMAT or IMRT | Radiation | 15Gy/5F (d43-d50, d57-d64), 5 times a week |
|
| Esophagectomy | Procedure | Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy |
|
| Up to 12 weeks |
| R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate | The R0 resection rate of esophagectomy | Three to five working days after surgery |
| Major pathological response | less than 10% residual viable tumor follow neoadjuvant therapy | Three to five working days after surgery |
| Overall survival | Overall survival rate | From the date of diagnosis to the date of death, assessed up to 100 months |
| Event-free survival | EFS | From the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months |
| Dysphagia relief score | DRS | score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D003680 | Deglutition Disorders |
| 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 |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| C000707970 | tislelizumab |
| D050397 | Radiotherapy, Intensity-Modulated |
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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