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At present, the treatment of advanced gastric/gastroesophageal junction cancer is a research hotspot in the academic community. In Asia, Siewert type II and type III are the main types of advanced gastric/gastroesophageal junction cancer. The current consensus in the academic community for the treatment of this part of the tumor is based on the principles of diagnosis and treatment of gastric cancer, of which the value of neoadjuvant therapy in this part of the tumor has been paid more and more attention by scholars. However, there is no highly recognized neoadjuvant therapy. The current situation will promote the development of advanced gastric/gastroesophageal junction cancer to accurate preoperative staging, more accurate population screening, more accurate targets and molecular markers. Immunotherapy is a promising application in oncology. Several PD1/PD-L1 monoclonal antibodies are approved by FDA for the clinical treatment of melanoma and other tumors. Previous clinical studies have shown that PD1/PD-L1 has limited efficacy in digestive tract tumors. However, on ASCO in 2020, Asian analysis of KEYNOTE-062 study showed that in HER-2 negative advanced gastric cancer with PD-1 combined positive score (CPS) ≥ 1 and CPS ≥ 10, the OS of PD-1 inhibitor treatment was superior to that of chemotherapy group, with 24-month OS rate (CPS ≥ 1, 45% VS 23%, CPS ≥ 10, 54% VS 27%). Meanwhile, the results of PACIFIC study phase III clinical trial showed that the 3-year OS of PD-L1 monoclonal antibody combined with radiotherapy in advanced unresectable lung cancer was as high as 57%, which is expected to completely rewrite its clinical practice. Immunotherapy is promising in cancer therapy. This study intends to use immunotherapy combined with SOX (S-1 + Oxaliplatin) as a neoadjuvant therapy for advanced gastric/gastroesophageal junction cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 with SOX | Experimental | S-1: 40~60mg Bid,d1~14, q3w Oxaliplatin:130mg/m2,iv drip for 2h,d1, q3w PD-1(Tislelizumab):200mg,iv drip for at least 1h,d1,q3w |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin) | Drug | S-1: 40~60mg Bid,d1~14, q3w. Oxaliplatin:130mg/m2,iv drip for 2h,d1, q3w. PD-1(Tislelizumab):200mg,iv drip for at least 1h,d1,q3w. Stage I: PD1 inhibitor + SOX regimen (q3W) . Stage II: PD1 inhibitor + SOX regimen (q3W) Stage III: PD1 inhibitor + SOX regimen (q3W) . Efficacy evaluation,then followed by surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Defined as the proportion of patients whose tumors shrink for a certain period of time | From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time | From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years |
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Inclusion Criteria:
Obtaining written informed consent from patient in advance.
Gastroscopy confirmed adenocarcinoma of the gastroesophageal junction or stomach and biopsy pathology confirmed adenocarcinoma of the stomach.
ECOG 0-1
Normal function of major organs, meeting the following criteria:
Blood routine test criteria should be met (Patients for 14 days were not transfused with blood products and not corrected with G-CSF and other hematopoietic stimulating factors)
Chemistry panel meeting the following criteria:
Women of childbearing potential must have used reliable contraception or had a pregnancy test (serum or urine) within 7 days prior to enrollment and had a negative result, and be willing to use an appropriate method of contraception during the trial and for 8 weeks after administration of the trial drug. For men, agree to use an appropriate method of contraception or have been surgically sterilized during the trial and for 8 weeks after receiving study drug.
Advanced gastric cancer as assessed by ultrasonography and/or gastric CT (cT3-T4a, N+, M0).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College of HUST | Recruiting | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36158692 | Derived | Yin Y, Lin Y, Yang M, Lv J, Liu J, Wu K, Liu K, Li A, Shuai X, Cai K, Wang Z, Wang G, Shen J, Zhang P, Tao K. Neoadjuvant tislelizumab and tegafur/gimeracil/octeracil (S-1) plus oxaliplatin in patients with locally advanced gastric or gastroesophageal junction cancer: Early results of a phase 2, single-arm trial. Front Oncol. 2022 Aug 30;12:959295. doi: 10.3389/fonc.2022.959295. eCollection 2022. |
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|
| pCR rate |
Pathological complete response |
| From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks. |
| R0 resection rate | Rate of microscopically margin-negative resection | From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks. |
| postoperative complications | Complications refer to the occurrence of another or several diseases related to the therapeutic behavior of this disease during the treatment of a certain disease | Investigator assessment,from the initiation date of the operation day, assessed up to 1 years. |