Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Shanghai OneTar Biomedicine Co., Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Neoadjuvant chemotherapy has become the mainstream recommended treatment for advanced gastric cancer. However, due to the heterogeneity of gastric cancer, part of some patients fail to benefit from the treatment. This project aims to compare the clinical efficacy of individualized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay and traditional regimen, exploring the advantages and disadvantages of these two treatments. And access the safety and clinical value of the personalized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay in advanced gastric cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDO group | Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay. |
| |
| Traditional group | Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDO group | Drug | Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | proportion of patients whose tumor volume reduced to a predetermined value and maintain the minimum time limit. | an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complication | postoperative complication | an average of 1 year |
| postoperative tumor regression grading | grade the pathological response of tumor after neoadjuvant treatment, which is usually classified according to the proportion of fibrosis and residual tumor in tumor tissues. |
Not provided
Inclusion Criteria:
A. preoperative staging cT3-4N1-2 B. excluding distant organ metastasis (M0)
Exclusion Criteria:
Not provided
Not provided
Patients with advanced gastric cancer whose tumor is located in the stomach and need neoadjuvant therapy before radical surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Sun, PhD | Contact | +86-21-64370045 | sj11788@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jing Sun, PhD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ruijin Hospttal | Shanghai | Sahnghai | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33734139 | Result | Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474. | |
| 30460342 | Result | Kanaji S, Suzuki S, Matsuda Y, Hasegawa H, Yamamoto M, Yamashita K, Oshikiri T, Matsuda T, Nakamura T, Sumi Y, Kakeji Y. Recent updates in perioperative chemotherapy and recurrence pattern of gastric cancer. Ann Gastroenterol Surg. 2018 Aug 29;2(6):400-405. doi: 10.1002/ags3.12199. eCollection 2018 Nov. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Traditional group | Drug | Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen. |
|
| an average of 1 year |
| 3-year recurrence rate | proportion of patients who relapse within 3 years after operation | an average of 3 year |
| chemotherapy tolerance and adverse reaction rate | an average of 1 year |
| R0 resection rate | an average of 1 year |
| 16822992 | Result | Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531. |
| 20706861 | Result | Oh SY, Kwon HC, Jeong SH, Joo YT, Lee YJ, Cho Sh, Kang MH, Go SI, Lee GW, Kim Hg, Kang JH. A phase II study of S-1 and oxaliplatin (SOx) combination chemotherapy as a first-line therapy for patients with advanced gastric cancer. Invest New Drugs. 2012 Feb;30(1):350-6. doi: 10.1007/s10637-010-9507-2. Epub 2010 Aug 13. |
| 31897343 | Result | Xu R, He X, Wufuli R, Su Y, Ma L, Chen R, Han Z, Wang F, Liu J. Choice of Capecitabine or S1 in Combination with Oxaliplatin based on Thymidine Phosphorylase and Dihydropyrimidine Dehydrogenase Expression Status in Patients with Advanced Gastric Cancer. J Gastric Cancer. 2019 Dec;19(4):408-416. doi: 10.5230/jgc.2019.19.e40. Epub 2019 Nov 13. |
| 29472484 | Result | Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774. |
| 28126704 | Result | Driehuis E, Clevers H. CRISPR/Cas 9 genome editing and its applications in organoids. Am J Physiol Gastrointest Liver Physiol. 2017 Mar 1;312(3):G257-G265. doi: 10.1152/ajpgi.00410.2016. Epub 2017 Jan 26. |