Phase 3 Clinical Trial for Tislelizumab in Gastric Cancer Patients Aims to Evaluate Efficacy and Safety

Strategic Insights -

Researchers at Sichuan Cancer Hospital and Research Institute, along with Liaoning Cancer Hospital & Institute, are conducting a Phase 3 clinical trial to examine the effectiveness of tislelizumab combined with chemotherapy for patients with MHC Class II-positive locally advanced gastric or gastroesophageal junction adenocarcinoma. The study is inspired by previous research demonstrating that patients with upregulated MHC-II expression in malignant cells exhibit better treatment outcomes with immunotherapy plus chemotherapy. With a sample size of 470 participants from the USA, this trial aims to evaluate the efficacy and safety of this treatment approach.

Key Takeaways:

  • The Phase 3 clinical trial, NCT07068516, will investigate the efficacy and safety of tislelizumab combined with chemotherapy versus placebo plus chemotherapy for MHC-II positive patients with locally advanced gastric or gastroesophageal junction adenocarcinoma.
  • The study builds upon previous research, including a prospective single-arm trial (NCT05739045), which demonstrated that 21.74% of patients achieved pathological complete response (pCR) after receiving neoadjuvant nivolumab combined with SOX regimen.
  • The pCR rate was significantly higher in MHC-II positive patients compared to MHC-II negative patients (36.84% vs 11.11%, P=0.038).
  • The study aims to enroll 470 participants from the USA and will be conducted in collaboration with Sichuan Cancer Hospital and Research Institute and Liaoning Cancer Hospital & Institute.
  • The sensitive group exhibited upregulated MHC-II expression in malignant cells at baseline, with enriched pathways including interferon-gamma signaling and MHC class II antigen presentation.

Statistics:

  • 21.74% of patients achieved pathological complete response (pCR) after receiving neoadjuvant nivolumab combined with SOX regimen in a prospective single-arm trial (NCT05739045).
  • 36.84% of MHC-II positive patients achieved pCR compared to 11.11% of MHC-II negative patients (P=0.038).
  • The study aims to enroll 470 participants from the USA.
  • The pCR rate was significantly higher in MHC-II positive patients, indicating a potential therapeutic benefit for this subgroup.

Sources:

  • ClinicalTrials.gov: NCT07068516 - Phase 3 Study of Tislelizumab Combined With Chemotherapy Versus Placebo Plus Chemotherapy as Perioperative Treatment for MHC Class II-positive Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.