Tislelizumab with chemotherapy in first-line advanced ESCC in Japanese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, open-label trial in Japan compares two dosing schedules of tislelizumab (Q2W or Q4W) in combination with FOLFOX as first-line therapy for unresectable locally advanced, recurrent, or metastatic ESCC. Participants are adults with no prior systemic therapy for unresectable/metastatic disease and measurable tumors, and ECOG 0-1. The study primarily assesses safety and pharmacokinetics, while exploring tumor response. It includes an initial 10-patient randomization to Group 1 or Group 2 before all participants receive Group 2 treatment. The trial is sponsored by BeOne Medicines and conducted at three Japanese cancer centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to provide written informed consent by the participant or by the participants' legally acceptable representative and can understand and agree to comply with the requirements of the study
* Histologically confirmed, unresectable locally advanced, recurrent or metastatic ESCC not amenable to curative approaches such as definitive chemoradiation or surgery.
* No previous systemic therapy for unresectable locally advanced, recurrent or metastatic ESCC
* At least 1 measurable lesion per RECIST v1.1 as determined by investigator
* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1
* Adequate organ function as indicated by the laboratory values ≤ 14 days prior to the first dose of study drugs
* Females of childbearing potential must have a negative urine or serum pregnancy test≤ 7 days prior to the first dose of study drugs and be willing to use a highly effective method of birth control for the duration of the study until at least 120 days after the last dose of tislelizumab. Further contraception requirements after completing chemotherapy should follow the approved product labeling for each specific cytotoxic agent

Exclusion Criteria:

* Participants who are unable to comply with the requirements of the protocol
* Participants with evidence of esophageal or gastroesophageal perforation or fistula ( esophageal/bronchial or esophageal/aorta), or complete esophageal obstruction not amenable to treatment within 6 months prior to the first dose of study drugs
* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention) and/or diuretics within 7 days prior to the first dose of study drugs (the cytological confirmation of any effusion is permitted)
* Have an estimated life expectancy \< 3 months, per the judgment of the investigator
* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Prior therapy with anti-programmed death protein-1 (anti-PD-1), anti-programmed death protein ligand-1(anti-PD-L1), anti-programmed death protein ligand- 2 (anti-PD-L2), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• Kanagawa Cancer Center
  Yokohama, Kanagawa, Japan Recruiting
• Osaka Medical and Pharmaceutical University Hospital
  Takatsukishi, Osaka, Japan Recruiting
• National Cancer Center Hospital
  ChuoKu, Tokyo, Japan Recruiting
• Osaka Keisatsu Hospital
  Osaka, Japan Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1-877-828-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.