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

NCT07733180 | Not Yet Recruiting Phase 2

• 1 other identifier: BGB-A317-216
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

ESCC; Metastatic esophageal squamous cell carcinoma; Advanced esophageal squamous cell carcinoma; Japanese population

Outcome Measures

Primary Outcomes (3)

• Serum Concentrations of Tislelizumab at Specified Time Points

  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

  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

  Approximately 12 months

Secondary Outcomes (1)

• Progression-Free Survival (PFS) Rate at 6 Months

  6 months

Study Arms (2)

Arm A: Tislelizumab Q2W + FOLFOX regimen

EXPERIMENTAL

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 regimen

EXPERIMENTAL

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; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-fluorouracil (5-FU)

Interventions

Tislelizumab DRUG

Administered by intravenous infusion

Arm A: Tislelizumab Q2W + FOLFOX regimen; Arm B: Tislelizumab Q4W + FOLFOX regimen

Oxaliplatin DRUG

Administered by intravenous infusion

Arm A: Tislelizumab Q2W + FOLFOX regimen; Arm B: Tislelizumab Q4W + FOLFOX regimen

Leucovorin DRUG

Administered by intravenous infusion

Arm A: Tislelizumab Q2W + FOLFOX regimen; Arm B: Tislelizumab Q4W + FOLFOX regimen

5-fluorouracil (5-FU) DRUG

Administered by intravenous infusion

Arm A: Tislelizumab Q2W + FOLFOX regimen; Arm B: Tislelizumab Q4W + FOLFOX regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeOne Medicines: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

tislelizumab; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1-877-828-5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description