A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC

Official record

Identifier

NCT07733180

Recruiting locations

Locations are not included in the offline baseline for this record. Open the official record to see the current site list.

Interventions studied

TislelizumabOxaliplatinLeucovorin5-fluorouracil (5-FU)

Lead sponsor

BeOne Medicines

Target enrolment

30 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Not yet recruiting

First posted

Jul 29, 2026

Last updated on the registry

Jul 29, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Esophageal Cancer