The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of tislelizumab administered once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in combination with chemotherapy as first-line treatment in Japanese participants with previously untreated, unresectable locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC).
Esophageal squamous cell carcinoma (ESCC) is a type of cancer that starts in the flat cells lining the inside of the esophagus (food pipe), the tube that carries food from the mouth to the stomach. In advanced stages, the cancer spreads to nearby tissues or other parts of the body. Tislelizumab is used to block the programmed cell death protein-1 pathway so that immune system cells (T-cells) can better protect the body from infection and find tumor cells to attack. Tislelizumab may be used in combination with other therapies as a promising approach with potential therapeutic benefits to treat participants with cancer. The purpose of this study is to test whether tislelizumab is safe and can help treat esophageal squamous cell carcinoma. The main goal of the study is to ensure that the treatments are safe by monitoring side effects and to understand how well participants respond to the treatment and whether their cancers shrink or disappear. This study consists of two treatment groups. The first 10 participants will be randomly assigned (by chance, like flipping a coin) to one of two treatment groups; after that all participants will be assigned to Group 2.The study is open label, which means that the participants and the study doctors will know what treatment they receive. Group 1: Tislelizumab every 2 weeks plus FOLFOX chemotherapy (oxaliplatin, leucovorin, and 5-FU) given by intravenous (IV) infusion every 2 weeks Group 2: Tislelizumab every 4 weeks plus FOLFOX chemotherapy (oxaliplatin, leucovorin, and 5-FU) given by intravenous (IV) infusion every 2 weeks The study will enroll approximately 30 participants in Japan with ESCC. The overall time to participate in this study is approximately 1 year. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and for tumor and imaging tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Osaka Keisatsu Hospital
Osaka, Japan
RECRUITINGSerum Concentrations of Tislelizumab at Specified Time Points
Time frame: Approximately 12 months
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAEv5.0) timing, seriousness, and relationship to study treatment
Time frame: Approximately 12 months
Overall Response Rate (ORR)Assessed by Independent Review Committee (IRC)
ORR is defined as the percentage of participants with partial or complete response, as assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 12 months
Progression-Free Survival (PFS) Rate at 6 Months
Six-month progression-free survival (PFS) rate, defined as the percentage of participants free from first documentation of disease progression assessed by the IRC using RECIST v1.1, or death, whichever comes first, for six months after first dose
Time frame: 6 months
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