NCT05507658

Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma

Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma: A Single-center, Single-arm, Phase Ⅱ Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Locally Advanced Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab combined with Oxaliplatin and Capecitabine	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.

Timeline

• Start date: 2022-07-18
• Primary completion: 2023-07-02
• Completion: 2025-10-10
• First posted: 2022-08-19
• Last updated: 2025-11-28

Locations

1 site across 1 country: China