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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Xiangya Hospital of Central South University | OTHER |
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We plan to evaluate the efficacy and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer
Gastric cancer is one of the most common malignant tumors in China, and its morbidity and mortality rank among the top three for a long time.How to improve the survival rate of patients with advanced gastric cancer is the key to improve the prognosis.At present, neoadjuvant chemotherapy combined with immunosuppressants has a higher pathologic complete response (pCR) rate, reduce the clinical stage of tumors and improve the resection rate of radical surgery.Some studies have suggested that preserving partial gastric lymph nodes may enhance immunotherapy efficacy.Proximal radical gastrectomy versus total radical gastrectomy can reduce the scope of surgical resection and preserve some lymph nodes, which may contribute to long-term survival and improve postoperative quality of life of patients. It is expected to translate the short-term benefit of neoadjuvant immunotherapy into the benefit of patient overall survival (OS) rate.At the same time, our previous studies have shown that the methylation level of PD-L1 K162 can be used as a new indicator to predict the sensitivity of anti-PD -(L)1 immunotherapy, which is expected to be further confirmed in this clinical trial.Therefore, we plan to conduct a comparative study on the effectiveness and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy for locally advanced upper gastric cancer, which is expected to propose new changes in surgical methods for gastric cancer and a new indicator for screening the advantages of gastric cancer immunotherapy in the era of immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proximal radical gastrectomy group | Experimental | Patients with locally advanced upper gastric cancer were enrolled for 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After the completion of neoadjuvant therapy, the efficacy was evaluated, and the patients were divided into two groups according to the remission of lesions: (1) PD (Progressive disease) and SD (Stable disease) patients were replaced with conservative treatment or surgical treatment after MDT (Multi-disciplinary Treatment) discussion; (2) For PR (Partial response) and CCR (Clinical complete response) patients, if the patients met the criteria for proximal gastric radical surgery, the enrolled patients were randomly divided into 2 cohorts, which were divided into experimental group : the group of proximal gastric radical surgery; Four cycles of SOX combined with anti-PD-1 adjuvant therapy continued after surgery, and anti-PD-1 adjuvant therapy lasted for 1 year. |
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| Total radical gastrectomy group | Active Comparator | Patients with untreated, operable locally advanced upper gastric cancer who signed informed consent and met the screening criteria were enrolled for 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After the completion of neoadjuvant therapy, the efficacy was evaluated, and the patients were divided into two groups according to the remission of lesions: (1) PD and SD patients were replaced with conservative treatment or surgical treatment after MDT discussion; (2) For PR and CCR patients, if the patients met the criteria for proximal gastric radical surgery, the enrolled patients were randomly divided into 2 cohorts, Cohort 2 (control group) : total radical gastrectomy group. Four cycles of SOX combined with anti-PD-1 adjuvant therapy continued after surgery, and anti-PD-1 adjuvant therapy lasted for 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proximal radical gastrectomy | Procedure | Proximal radical gastrectomy : Dissection of lymph nodes No.1,2,3a,4sa,4sb,7,8a, 9, 11p, 11dare recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: double channel anastomosis is recommended, and other anastomosis methods can be carried out according to the surgeon's habit. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Disease-free survival (DFS) | DFS is based on RECIST(Response Evaluation Criteria in Solid Tumours) 1.1 as assessed by the investigator and is defined as the time from surgery initiation to the date of first documentation of disease recurrence or death due to any cause | UP to 3 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| major pathologic response (MPR) | defined as the percentage of residual viable tumour cells in the tumour bed of no more than 10% after neoadjuvant therapy. | an average of 2 to 4 weeks after surgery |
| R0 resection rate |
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Inclusion Criteria:
To be eligible to participate in this study, all patients must meet all the following criteria:
Exclusion Criteria:
To be eligible to participate in this study, all patients must meet all the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guihua Wang | Contact | +86-027-83665215 | ghwang@tjh.tjmu.edu.cn | |
| lisheng chen | Contact | +86-13797056427 | clsmail1990@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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partial data will be shared 3 years after the study was completed and end in 5 years.
A shared data acquisition scheme approved by the researcher
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| Shandong First Medical University |
| OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| The First Medical Center of Chinese PLA General Hospital | OTHER |
| Affiliated Hospital of Qinghai University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Ruijin Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Southern Medical University, China | OTHER |
| Shanxi Bethune Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| Jingzhou Central Hospital | OTHER |
| Xiangyang Central Hospital | OTHER |
| Yichang Central People's Hospital | OTHER |
| The First Affiliated Hospital of University of South China | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| People's Hospital of Macheng City | UNKNOWN |
| Southwest Hospital, China | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| RenJi Hospital | OTHER |
| Changhai Hospital | OTHER |
| The First Affilated Hospital of the Medical College, Shihezi University | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| First Hospital of China Medical University | OTHER |
| Shanghai East Hospital | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| Shanghai Changzheng Hospital | OTHER |
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| Total radical gastrectomy | Procedure | total radical gastrectomy : Dissection of lymph nodes No.1-7, 8a, 9, 11p, 11d, 12a are recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: Roux⁃en⁃Y anastomosis is recommended |
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defined as the absence of tumor cells present at the resection margin under microscope
| an average of 2 to 4 weeks after surgery |
| Overall Survival (OS) | defined as the time from randomization to death due to any cause. | UP to 5 years after surgery |
| Percentage of Participants Who Experience One or More Adverse Events (AEs) | An AE is based on NCI-CTC (The National Cancer Institute Common Toxicity Criteria) 5.0 as assessed by the investigator and is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be presented. | Up to approximately 36 months |
| nutritional status | Nutrition was assessed with the patient-generated subjective global assessment (PG-SGA). | UP to 3 years after surgery |
| quality of life,EORTC QLQ-C30 | Questionnaire includes EORTC QLQ-C30 (The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30))(version 3), | UP to 3 years after surgery |