A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC | NCT07733180

NCT07733180

Overview

NCT ID: NCT07733180
Lead Sponsor: BeOne MedicinesINDUSTRY
Official Title: A Phase 2 Study of Tislelizumab Administered With Alternative Dosing Schedules Plus Chemotherapy as First-line Treatment in Japanese Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Brief Summary: 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).
Conditions: Advanced Esophageal Squamous Cell Carcinoma
Metastatic Esophageal Squamous Cell Carcinoma

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Aug 31, 2026Estimated
Primary Completion Date: Feb 28, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 30Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Study DirectorContact
clinicaltrials@beonemed.com1-877-828-5568

Similar Studies

Participant Group/Arms

Arm A: Tislelizumab Q2W + FOLFOX regimenExperimental

Participants will receive tislelizumab 150 mg every 2 weeks and FOLFOX chemotherapy regiment (Oxaliplatin 85 mg/m2, l-leucovorin 200 mg/m2, and a bolus injection of 5-FU 400 mg/m2) intravenously on Day 1, followed by a 46-hour continuous infusion of (5-FU 2400 mg/m2) dosed every 2 weeks, administered per local standards or guideline, until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: Tislelizumab

Drug: Oxaliplatin

Drug: Leucovorin

Drug: 5-fluorouracil (5-FU)

Arm B: Tislelizumab Q4W + FOLFOX regimenExperimental

Participants will receive tislelizumab 300 mg every 4 weeks and FOLFOX chemotherapy regiment (Oxaliplatin 85 mg/m2, l-leucovorin 200 mg/m2, and a bolus injection of 5-FU 400 mg/m2) intravenously on Day 1, followed by a 46-hour continuous infusion of (5-FU 2400 mg/m2); dosed every 2 weeks, administered per local standards or guideline, until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: Tislelizumab