The effective treatment of G/GEJ adenocarcinoma has always been a research hotspot in academia. In recent years, mainstream studies have shown that the treatment mode of G/GEJ adenocarcinoma has changed from single surgery mode in the past, to multi-disciplinary comprehensive treatment mode for now, which is based on surgery. Several studies indicate that for most late-stage G/GEJ adenocarcinoma, the neoadjuvant treatment model can further enhance the survival rates and prognosis of patients, compared with the combination of standard radical resection and postoperative adjuvant chemotherapy. According to The Chinese Society of Clinical Oncology (CSCO): clinical guidelines for the diagnosis and treatment of gastric cancer (Wang et al , 2021), neoadjuvant therapy and adjuvant therapy are recommended for patients with G/GEJ adenocarcinoma. However, there is still a lack of unified standards and norms for precise preoperative staging of gastric cancer, applicable population of neoadjuvant along with adjuvant therapy, and the selection of treatment regimens. Therefore, this project is aimed to carry out a single-arm, open-label, phase II clinical trial to administer tirelizumab plus XELOX for neoadjuvant management of patients diagnosed with resectable gastroesophageal junction or stomach cancer, and further explore the safety and therapeutic effect of chemotherapy together with tirelizumab in the neoadjuvant period of G/GEJ adenocarcinoma, eventually, providing a new option for the neoadjuvant treatment of G/GEJ adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Drugs: 1. Tistelizumab 200mg, iv.gtt, D1, Q3W; 2. Chemotherapy (XELOX) : oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W. Neoadjuvant therapy: 1. Tislelizumab combined with XELOX, Q3W, for 2\~3 cycles; 2. D2 radical gastrectomy after neoadjuvant therapy. Adjuvant therapy: 1. From 4 to 8 weeks after surgery, the treatment dose was the same as above; 2. Patients who achieved MPR and non-MPR on pathological evaluation were treated with tirelizumab +XELOX 3\~8 cycles; 3. Tumor evaluation performed every 3 cycles; 4. The maximum duration of adjuvant therapy was not more than 8 cycles.
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Major pathological response rate(MPR)
Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time.
Time frame: 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
Pathological complete response rate(pCR)
Pathological complete response
Time frame: 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
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
TRAEs and postoperative complications
Including TRAEs and 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.
Time frame: Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.
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