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To evaluate the initial efficacy and safety of neoadjuvant low-dose interval radiotherapy combined with tirelizumab and SOX chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Therapy(5×3Gy radiotherapy) | Radiation | Radiotherapy: 5×3Gy. The preoperative radiotherapy target was outlined by radiotherapy physicians according to the NCCN Guidelines for Gastric/esophagogastric Junction Tumor 2024 edition and the surgeon's opinions. The first and third cycles were 5×3Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate (pCR) | Pathological complete response was defined as pT0N0M0 | From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response rate (MPR) | The percentage of surviving tumor cells in the tumor bed after neoadjuvant therapy was ≤10%. | From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks. |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Shang | Contact | +8615866602157 | docshang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | 250021 | China |
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| Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1) | Drug | The first and third cycles are 5×3Gy radiotherapy D1 to 5, intravenous administration for tirelizumab 200 mg D6, intravenous administration for oxaliplatin 130 mg/m2 D6, and oral administration twice a day for S-1 40 mg/m2 D6 to 19. The second and fourth cycles are intravenous administration for tirelizumab 200 mg D1, intravenous administration for oxaliplatin 130 mg/m2 D1, and oral administration twice a day for S-1 40 mg/m2 D1 to 14. Every treatment cycle is spaced 1 week apart. |
|
| Surgical treatment | Procedure | Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy. |
|
| Adjuvant therapy(SOX chemotherapy) | Drug | Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy. |
|
Proportion of patients who achieved a complete response (CR) or a partial response (PR) as assessed by RECIST 1.1. |
| From date of neoadjuvant therapy until the date of surgery, assessed up to 15-17 weeks. |
| R0 resection rate | The proportion of patients who completed R0 resection in the total enrolled patients. | From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks. |
| Treatment safety | CTCAE 5.0 was used to record grade 3 and above treatment-related adverse reactions from the beginning of neoadjuvant therapy to 30 days after the end of surgery. | From date of neoadjuvant therapy until the date of 30 days post-surgery, assessed up to 19-21 weeks. |
| Postoperative complications | Clavien-Dindo criteria were used to evaluate. | The first 30 days following surgery. |
| Event-free survival (EFS) | From the beginning of the study to the time of the first occurrence of any of the following events, disease progression beyond surgical treatment, local or distant recurrence, death from any cause, etc. | From date of neoadjuvant therapy until the date of the first occurrence of the above events, assessed up to 60 months. |
| Overall survival (OS) | From study inception to patient death from any cause. | From the date of diagnosis to the date of death, assessed up to 60 months. |
| Biomarkers | By collecting tumor tissue and hematology samples before and after neoadjuvant therapy, scRNA-seq, WES, MRD and other techniques were used to explore biomarkers related to the efficacy of immunotherapy combined with radiotherapy and chemotherapy. | From the date of neoadjuvant therapy until the end of postoperative follow-up, assessed up to 60 months. |
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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