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| Name | Class |
|---|---|
| Shanghai Junshi Bioscience Co., Ltd. | OTHER |
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In this study, patients with advanced gastric adenocarcinoma whose peritoneal metastasis and peritoneal nodule pathologically confirmed metastasis and/or exfoliative cytology were confirmed as the clinical stage of peritoneal metastasis, who had not received treatment before, were invited to participate in the study.To evaluate the surgical conversion rate and tumor regression grade (TRG grade) of patients with stage gastric cancer with peritoneal metastasis using docetaxel, oxaliplatin, fluorouracil (FLOT regimen) combined with teriprizumab (PD-1).
The study drugs in this study are docetaxel, oxaliplatin, 5-FU, leucovorin, tigio capsules and teriprizumab.
Dosage and dosing regimen for all research phases:
The enrolled patients will receive 4 cycles of FLOT regimen + teriprizumab treatment before surgery, and every 2 weeks is a treatment cycle (Q2W). The specific plan is as follows.
After completing the 4 cycles of treatment, oral Tiggio Capsule (S-1) and Teriprizumab were maintained for 1 year. The specific plan is as follows.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLOT combined with PD-1 | Experimental | The enrolled patients will receive 4 cycles of FLOT regimen + teriprizumab treatment before surgery Q2W. If the transformation is successful, the patient undergoes R0 surgical resection of D2 lymph node dissection, and will continue to receive 4 cycles of FLOT regimen + Teripril after surgery. Anti-treatment, the treatment plan is the same as before. After completing the 4 cycles of treatment, oral Tiggio Capsule (S-1) and Teriprizumab were maintained for 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU), Treprizumab, Tiggio capsule (S-1) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical conversion rate | defined as the proportion of patients who have undergone R0 surgical resection after multidisciplinary assessment after completing 4 courses of conversion adjuvant therapy | 2-3 months |
| TRG grade | tumor regression grade | 2-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival | 1 year |
| OS | overall survival | 1 year |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24107642 | Background | Yamamoto M, Sakaguchi Y, Matsuyama A, Yoshinaga K, Tsutsui S, Ishida T. Surgery after preoperative chemotherapy for patients with unresectable advanced gastric cancer. Oncology. 2013;85(4):241-7. doi: 10.1159/000354420. Epub 2013 Oct 4. | |
| 16617004 | Background | Yonemura Y, Bandou E, Kawamura T, Endou Y, Sasaki T. Quantitative prognostic indicators of peritoneal dissemination of gastric cancer. Eur J Surg Oncol. 2006 Aug;32(6):602-6. doi: 10.1016/j.ejso.2006.03.003. Epub 2006 Apr 17. |
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|
| the incidence and severity of adverse events |
the incidence and severity of adverse events |
| 1 year |
| 23975319 | Background | Kitayama J, Ishigami H, Yamaguchi H, Yamashita H, Emoto S, Kaisaki S, Watanabe T. Salvage gastrectomy after intravenous and intraperitoneal paclitaxel (PTX) administration with oral S-1 for peritoneal dissemination of advanced gastric cancer with malignant ascites. Ann Surg Oncol. 2014 Feb;21(2):539-46. doi: 10.1245/s10434-013-3208-y. Epub 2013 Aug 22. |
| 9609107 | Background | Bismuth H, Adam R. Reduction of nonresectable liver metastasis from colorectal cancer after oxaliplatin chemotherapy. Semin Oncol. 1998 Apr;25(2 Suppl 5):40-6. |
| 9142380 | Background | Nakajima T, Ota K, Ishihara S, Oyama S, Nishi M, Ohashi Y, Yanagisawa A. Combined intensive chemotherapy and radical surgery for incurable gastric cancer. Ann Surg Oncol. 1997 Apr-May;4(3):203-8. doi: 10.1007/BF02306611. |
| 28616743 | Background | Yamaguchi K, Yoshida K, Tanahashi T, Takahashi T, Matsuhashi N, Tanaka Y, Tanabe K, Ohdan H. The long-term survival of stage IV gastric cancer patients with conversion therapy. Gastric Cancer. 2018 Mar;21(2):315-323. doi: 10.1007/s10120-017-0738-1. Epub 2017 Jun 14. |
| 26643880 | Background | Yoshida K, Yamaguchi K, Okumura N, Tanahashi T, Kodera Y. Is conversion therapy possible in stage IV gastric cancer: the proposal of new biological categories of classification. Gastric Cancer. 2016 Apr;19(2):329-338. doi: 10.1007/s10120-015-0575-z. Epub 2015 Dec 7. |
| 30487951 | Background | Zurleni T, Gjoni E, Altomare M, Rausei S. Conversion surgery for gastric cancer patients: A review. World J Gastrointest Oncol. 2018 Nov 15;10(11):398-409. doi: 10.4251/wjgo.v10.i11.398. |
| 28993052 | Background | Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6. |
| 30207593 | Result | Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. |
| 26808342 | Result | Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. |
| 27776843 | Result | Al-Batran SE, Hofheinz RD, Pauligk C, Kopp HG, Haag GM, Luley KB, Meiler J, Homann N, Lorenzen S, Schmalenberg H, Probst S, Koenigsmann M, Egger M, Prasnikar N, Caca K, Trojan J, Martens UM, Block A, Fischbach W, Mahlberg R, Clemens M, Illerhaus G, Zirlik K, Behringer DM, Schmiegel W, Pohl M, Heike M, Ronellenfitsch U, Schuler M, Bechstein WO, Konigsrainer A, Gaiser T, Schirmacher P, Hozaeel W, Reichart A, Goetze TO, Sievert M, Jager E, Monig S, Tannapfel A. Histopathological regression after neoadjuvant docetaxel, oxaliplatin, fluorouracil, and leucovorin versus epirubicin, cisplatin, and fluorouracil or capecitabine in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4-AIO): results from the phase 2 part of a multicentre, open-label, randomised phase 2/3 trial. Lancet Oncol. 2016 Dec;17(12):1697-1708. doi: 10.1016/S1470-2045(16)30531-9. Epub 2016 Oct 22. |
| 27157491 | Result | Muro K, Chung HC, Shankaran V, Geva R, Catenacci D, Gupta S, Eder JP, Golan T, Le DT, Burtness B, McRee AJ, Lin CC, Pathiraja K, Lunceford J, Emancipator K, Juco J, Koshiji M, Bang YJ. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol. 2016 Jun;17(6):717-726. doi: 10.1016/S1470-2045(16)00175-3. Epub 2016 May 3. |
| 29543932 | Result | Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, Sun W, Jalal SI, Shah MA, Metges JP, Garrido M, Golan T, Mandala M, Wainberg ZA, Catenacci DV, Ohtsu A, Shitara K, Geva R, Bleeker J, Ko AH, Ku G, Philip P, Enzinger PC, Bang YJ, Levitan D, Wang J, Rosales M, Dalal RP, Yoon HH. Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial. JAMA Oncol. 2018 May 10;4(5):e180013. doi: 10.1001/jamaoncol.2018.0013. Epub 2018 May 10. |
| 41206442 | Derived | Zhang Z, Lin Z, Xu Y, Luo L, Zeng H, Xiong W, Chen Y, Peng Y, Yang T, Zheng Y, Li J, Huang H, Wang W. Toripalimab combined with FLOT chemotherapy as conversion therapy for gastric cancer with peritoneal metastasis: a single-arm, open-label, phase II trial. BMC Cancer. 2025 Nov 8;25(1):1733. doi: 10.1186/s12885-025-15166-w. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
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