Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

The primary study hypotheses are that:

Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.

Eligibility criteria

Qualifiers

Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3~4aN+M0 or T4bNanyM0 (AJCC Version 8)

Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1

Has adequate organ function.

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.

Disqualifiers

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.

Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.

Has an active infection requiring systemic therapy.

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.

Trial design

Treatments tested in this trial

  • Tislelizumab
  • S-1
  • Oxaliplatin
  • Nab paclitaxel
  • Radiation

Treatment groups

140 Participants
are divided into 3 treatment groups