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Chemoradiotherapy(CRT) is the main treatment for esophageal cancer patients with recurrent desease,and checkpoint blockade (PD-1) have been shown to be effective in advanced esophageal cancer. Therefore, PD-1 combined with chemoradiotherapy (CRT)may further improve the efficacy and become a new method for the treatment of esophageal cancer.This study intends to conduct a single-arm, prospective clinical study, aiming to evaluate the safety and efficacy of PD-1 combined with chemoradiotherapy(CRT) in patients with oligometastatic esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoradiotherapy Combined With PD-1 Antibody | Experimental | The arm received chemoradiotherapy, 50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week) to recurrent sites combined with chemotherapy(Cisplatin 75 mg/m2/day 1, and albumin paclitaxel 150 mg/m2/day 1 , every 3 weeks, 2 cycles ).PD-1 antibody (Tislelizumab) was performed simultaneously with concurrent chemoradiotherapy (Triprizumab 200mg,d1,every 3 weeks,2 cycles). After completion of chemoradiotherapy, PD-1 antibody was given continuously with 2-4 cycles of chemotherapy (the same regimen with concurrent chemotherapy) until 1 year or desease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody | Drug | 200mg, d1, q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional control rate | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with acute toxicities | Acute toxicities are evaluated by NCI-CTC version 5.0 | 10 week, from the start of treatment to 1 month after chemoradiotherapy |
| Tumor response rate |
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Inclusion Criteria:
•≥18 years;
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Beijing | Beijing Municipality | 100021 | China |
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| Chemoradiation |
| Radiation |
50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week |
|
| Albumin-Bound Paclitaxel | Drug | 150mg/m2, d1, q3W |
|
| Cisplatin | Drug | 75mg/m2, d1, q3W |
|
| 2-3 months |
| Progression free survival | 1 year, 2 year, 3 year |
| Overall survival | 1 year, 2 year, 3 year |
| Objective response rate | Objective Response Rate are evaluated by RECIST 1.1 | 5.5 week |
| Radiomics analysis | Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation. | 1 year, 2 year, 3 year, 5 year |
| Department 4th of Radiation Oncology, Anyang Cancer Hospital | Anyang | Henan | 455001 | China |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D059248 | Chemoradiotherapy |
| D000068196 | Albumin-Bound Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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