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Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive Chemoradiation | Placebo Comparator | This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment. |
|
| Chemoradiation Combined With Immunotherapy/targeting agents | Experimental | This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | 50-66Gy/1.8-2.2Gy/25-30f |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 1year | |
| Overall survival | 2 year | |
| Overall survival | 3 year | |
| Overall survival | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 1 year, 2 year, 3 year, 5 year | |
| Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy | 3 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of correlation between radiomics signature extracted by LASSO and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | 1 year, 2 year, 3 year, 5 year | |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wang, MD | Contact | +861013311583220 | beryl_wx2000@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department 4th of Radiation Oncology, Anyang Cancer Hospital | Recruiting | Anyang | Henan | 455001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40367097 | Derived | Yang X, Wang X, Xiao Q, Ge X, Yu N, Li J, Feng G, Zheng Z, Jiang Y, Lu L, Xia X, Deng L, Zhang T, Wang W, Liu W, Wang J, Xiao Z, Zhou Z, Bi N, Wang H, Chen C, Wang X. Definitive chemoradiotherapy combined with anti-PD-1 immunotherapy for inoperable esophageal squamous cell carcinoma: a multicenter real-world study. Cancer Biol Ther. 2025 Dec;26(1):2504726. doi: 10.1080/15384047.2025.2504726. Epub 2025 May 14. |
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| Platinum based chemotherapy | Drug | q1-3W according to physician's preference |
|
| Paclitaxel based chemotherapy | Drug | q1-3W according to physician's preference |
|
| Immunotherapy | Drug | Anti-PD-1/PD-L1 Antibody |
|
| 5-FU Analog based chemotherapy | Drug | W1-5 qW or d1-14, q3W according to physician's preference |
|
| Nimotuzumab | Drug | 200-400mg, d1,qW |
|
| Pathological response rate |
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells). |
| 3 months |
| R0 resection rate | 3 months |
| Locoregional recurrence free survival | 1 year, 2 year, 3 year, 5 year |
| Distant metastasis free survival | 1 year, 2 year, 3 year, 5 year |
| 1 year, 2 year, 3 year, 5 year |
| Target dealineation of organs at risk and their impact on the prognosis and adverse effects of radiotherapy | 1 year, 2 year, 3 year, 5 year |
| Target dealineation of clinical target volumn and their impact on the prognosis | 1 year, 2 year, 3 year, 5 year |
| Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University | Recruiting | Changsha | Hunan | 410031 | China |
|
| Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
|
| 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) | Recruiting | Beijing | 100021 | 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 |
|---|---|
| D011878 | Radiotherapy |
| D017671 | Platinum Compounds |
| D007167 | Immunotherapy |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D007287 | Inorganic Chemicals |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
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