Combining Tislelizumab with XELOX for treating advanced gastric cancer before surgery

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

This study is testing if combining the immunotherapy drug Tislelizumab with XELOX can help people with advanced stomach cancer do better before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Drugs / interventions: chemotherapy, tirelizumab
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT05507658 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Tislelizumab, an immunotherapy drug, in combination with XELOX (Oxaliplatin and Capecitabine) as neoadjuvant therapy for patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. The approach aims to enhance survival rates and improve patient prognosis by administering this combination treatment before surgical intervention. The study focuses on patients who have confirmed adenocarcinoma and meet specific staging criteria, with the goal of establishing a more effective treatment protocol for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with histologically confirmed locally advanced gastric adenocarcinoma who are eligible for radical surgical resection.

Not a fit: Patients with HER2-positive gastric cancer or those with distant metastases will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced gastric adenocarcinoma.

How similar studies have performed: Other studies have shown promising results with neoadjuvant therapies for gastric cancer, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent;
2. Aged 18-80 (including 18 and 80), both sexes;
3. ECOG score ≤1;
4. Biopsy histologically confirmed adenocarcinoma (including Lauren grade);
5. cT3-4a N+ M0 G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced CT (PET/CT), MRI or diagnostic laparoscopy;

Exclusion Criteria:

1. Histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified carcinoma;
2. Patients with HER2-positive status are excluded;
3. Patients with distant metastases other than primary gastric cancer (any M1 stage);
4. Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy);
5. Patients who can not undergo radical surgical resection (D2 radical resection);
6. Previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy and hormone therapy);
7. Previously received immunological drugs such as PD-1/PD-L1, CTLA-4 or other immunological or molecular targeted therapies;
8. When virological testing prior to screening showed any of the following:

   1. patients with active hepatitis (HBV DNA≥1\*103 copies or ≥200IU/mL);
   2. Anti - HCV positive;
   3. HIV positive;
9. Patients or their families refused to sign this informed consent form to participate in the study.

Where this trial is running

Xi'an, Shaanxi

• Xijing Hospital of Digestive Diseases — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Gang Ji, doctoral

Conditions Locally Advanced Gastric Adenocarcinoma