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This project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.
The incidence of Adenocarcinoma of esophagogastric junction (AEG) is increasing in recent years. According to the statistics of The National Cancer Center of Japan, the proportion of AEG in gastric adenocarcinoma increased from 2.3% in the middle of the 20th century to 10.3% in the beginning of this century, and the proportion of Siewert II in AEG increased from 28.5% to 57.3%. Due to the special biological characteristics of tumor in this region, its definition and surgical treatment principles are controversial.
For AEG, the clinical study results of neoadjuvant chemoradiotherapy + surgery + chemotherapy showed that the tumor stage could be reduced, R0 resection could be improved and overall survival could be improved, without increasing postoperative complications and mortality. Long-term follow-up results from the German TRIAL III of preoperative chemoradiotherapy for AEG (POET) showed that preoperative chemoradiotherapy reduced recurrence (5y-local recurrence: 21% vs. 38%) and prolonged survival (3y-OS: 46.7% vs. 26.1%), without a significant increase in treatment toxicity and perioperative complications . Although some patients with AEG were included in the resolve 、 prodigy and resolution study ,and the total population could benefit from postoperative adjuvant radiotherapy and chemotherapy, but it was uncertain whether the patients with AEG could benefit in Asia.
Therefore, this project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy | Drug | Durg:Camrelizumab: 200mg, iv, d1, q3w Durg :Oxaliplatin, 100mg/m2 , iv, d1, q3w Durg :Paclitaxel(Albumin Bound), 125mg/m2, iv, d1, d8, q3w; Durg :Radiotherapy, PGTV:45.1Gy/2.05Gy/ 22f; PTV:40.04Gy/1.82Gy/ 22f;Five days a week for more than four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response (PCR) | pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells yT0N | 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 3 years-Overall Survival (3y-OS) | Percentage of patients who survived 3 years after the start of randomized treatment | up to 3 years |
| years-Event free survival (3y-EFS) | Proportion of patients with event-free survival at 3 years after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Li, chief physician | Contact | 010-87788052 | liyongdoctor@126.com | |
| Geng Shu Gao, Vice president | Contact | 010-87788052 | gaoshugeng1susar@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shugeng Gao | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| up to 3 years |
| Disesease free survival(DFS) | Proportion of patients with disease-free survival at 3 years after randomization | up to 3 years |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. | From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 1 years |
| R0 resection rate | R0 resection rate is defined as the percentage of patients, relative to the total of enrolled subjects, undergoing R0 resection of primary tumour | 24 months |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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