Tislelizumab combined with chemoradiotherapy for advanced gastric cancer

Tislelizumab in Combination With Pre-operative Chemoradiotherapy Versus SOC for Patients With Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Multicenter, Randomized, Open-label, Phase IIB Trial

This study is testing if combining the immunotherapy drug Tislelizumab with chemoradiotherapy can help people with advanced stomach cancer do better before or after surgery compared to standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Drugs / interventions: pembrolizumab, chemotherapy, prednisone, Tislelizumab
• Locations: 3 sites (Wuhan, Hubei and 2 other locations)
• Trial ID: NCT05687357 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Tislelizumab, an immunotherapy drug, in combination with chemoradiotherapy for patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. The treatment is administered either before surgery (neoadjuvant) or after surgery (adjuvant) to assess its impact on achieving a complete pathological response at the time of surgery. The study compares this combination approach to standard treatment protocols to determine which yields better outcomes for patients.

Who should consider this trial

Good fit: Ideal candidates are adults with untreated localized gastric or gastroesophageal junction adenocarcinoma who meet specific health criteria.

Not a fit: Patients with additional malignancies or those requiring active treatment for other cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve surgical outcomes and survival rates for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating gastric cancer, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3\~4aN+M0 or T4bNanyM0 （AJCC Version 8）
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
3. Has adequate organ function.
4. Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
5. Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.

Exclusion Criteria:

1. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
2. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
3. Has an active infection requiring systemic therapy.
4. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
5. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.
7. Has an active autoimmune disease that has required systemic treatment in past 2 years.
8. Has a known history of human immunodeficiency virus (HIV) infection.
9. Has a known history of Hepatitis B or known active Hepatitis C virus infection (HBsAg positive with HBV DNA≥500 IU/ml；HCV：HCV antigen positive with HCV copies \>ULN).
10. Has had an allogenic tissue/solid organ transplant.
11. Has received a live vaccine within 30 days prior to the first dose of study treatment.
12. Female participants who are breastfeeding.

Where this trial is running

Wuhan, Hubei and 2 other locations

• Wuhan Tongji Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Shanxi Province Cancer Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jia Wei, MD

Conditions Gastric Cancer; Gastroesophageal-junction Cancer