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This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirelizumab combined with neoadjuvant chemotherapy | Experimental | Four cycles of tirolizumab combined with SOX/XELOX neoadjuvant chemotherapy regimen before surgery, followed by laparoscopic D2 gastric cancer radical surgery, and four cycles of adjuvant chemotherapy after surgery. |
|
| standard chemotherapy | Active Comparator | Four cycles of standard chemotherapy regimen (SOX/XELOX regimen) were administered before and after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirolizumab+SOX/XELOX | Drug | Tirolizumab combined with chemotherapy(SOX/XELOX) regimen. The SOX regimen consists of the drugs Tegilol (S-1) and Oxaliplatin. The XELOX regimen consists of the drugs oxaliplatin and capecitabine. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) | After neoadjuvant therapy, there were no residual surviving tumor cells in the tumor bed during the pathological remission assessment of postoperative specimens. | Less than 20 months |
| Objective Response Rate(ORR) | The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of complete response (CR) and partial response (PR) ratios, with ORR=CR+PR. | Less than 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival(DFS) | Time from randomization to disease recurrence or (for any reason) death. | Less than 20 months |
| Overall survival(OS) | Time from randomization to death (for any reason) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Surgery Institute, China PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39035212 | Background | Zheng R, Zhang S, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2016. J Natl Cancer Cent. 2022 Feb 27;2(1):1-9. doi: 10.1016/j.jncc.2022.02.002. eCollection 2022 Mar. | |
| Background | 曹毛毛;李贺;孙殿钦;何思怡;雷林;彭绩;陈万青. 2000-2019年中国胃癌流行病学趋势分析. 中华消化外科杂志. 2021;20(01):102-109. doi:10.3760/cma.j.cn115610-20201130-00746 | ||
| 35323331 |
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| SOX/XELOX | Drug | Simple chemotherapy regimen (SOX/XELOX regimen). The SOX regimen consists of the drugs Tegilol (S-1) and Oxaliplatin. The XELOX regimen consists of the drugs oxaliplatin and capecitabine. |
|
| Less than 20 months |
| Major Pathologic Response(MPR) | After preoperative treatment, the number of surviving tumors decreases below the threshold that can affect clinical prognosis. | Less than 20 months |
| The incidence of adverse events during treatment | Including adverse reactions related to immunotherapy and postoperative complications. Reflecting safety and tolerability. | Less than 20 months |
| Background |
| Hogner A, Moehler M. Immunotherapy in Gastric Cancer. Curr Oncol. 2022 Mar 2;29(3):1559-1574. doi: 10.3390/curroncol29030131. |
| Background | Xu J, Jiang H, Pan Y, et al. LBA53 Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): First results of a randomized, double-blind, phase III study. Ann Oncol. 2021;32:S1331. doi:10.1016/j.annonc.2021.08.2133 |
| 25941355 | Background | Emens LA, Middleton G. The interplay of immunotherapy and chemotherapy: harnessing potential synergies. Cancer Immunol Res. 2015 May;3(5):436-43. doi: 10.1158/2326-6066.CIR-15-0064. |
| 35030335 | Background | Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11. |
| 29637937 | Background | King GT, Sharma P, Davis SL, Jimeno A. Immune and autoimmune-related adverse events associated with immune checkpoint inhibitors in cancer therapy. Drugs Today (Barc). 2018 Feb;54(2):103-122. doi: 10.1358/dot.2018.54.2.2776626. |
| 30464684 | Background | Myers G. Immune-related adverse events of immune checkpoint inhibitors: a brief review. Curr Oncol. 2018 Oct;25(5):342-347. doi: 10.3747/co.25.4235. Epub 2018 Oct 31. |
| 28881921 | Background | Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, Jordan K; ESMO Guidelines Committee. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119-iv142. doi: 10.1093/annonc/mdx225. No abstract available. |
| 33538338 | Result | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. |