Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT07733180
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
A Phase 2 study testing Tislelizumab, Oxaliplatin and Leucovorin in people with Advanced Esophageal Squamous Cell Carcinoma and Metastatic Esophageal Squamous Cell Carcinoma, run by BeOne Medicines at 3 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
- What is being tested?
- Tislelizumab, Oxaliplatin and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesJapan
- Study dates
- 14 Sep 2026to 28 Feb 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital
ChuoKu, Tokyo, 104-0045
- Recruiting
Osaka Keisatsu Hospital
Osaka, 543-0042
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
About this study
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
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).
Read the detailed description
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.
- Conditions
- Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
- Being tested
- Tislelizumab, Oxaliplatin, Leucovorin, 5-fluorouracil (5-FU)
- Keywords
- ESCC, Metastatic esophageal squamous cell carcinoma, Advanced esophageal squamous cell carcinoma, Japanese population
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Administered by intravenous infusion
OxaliplatinDrug
Administered by intravenous infusion
LeucovorinDrug
Administered by intravenous infusion
5-fluorouracil (5-FU)Drug
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tislelizumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-fluorouracil (5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Concentrations of Tislelizumab at Specified Time Points
Measured: 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
Measured: 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
Measured: Approximately 12 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start14 Sep 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733180
- Sponsor's protocol ID
- BGB-A317-216
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.