A Phase 2 interventional study of Tislelizumab and Oxaliplatin in Advanced Esophageal Squamous Cell Carcinoma and Metastatic Esophageal Squamous Cell Carcinoma, sponsored by BeOne Medicines. Recruiting at 4 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by BeOne Medicines · Phase 2, Interventional, and Treatment
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Among 23 studies testing tislelizumab in Esophageal Squamous Cell Carcinoma — 13 open to participants now, 15 under way, 1 of them phase 3. tislelizumab · Esophageal Squamous Cell Carcinoma.
Among the 23 studies testing tislelizumab in Esophageal Squamous Cell Carcinoma, this one is the 18th largest by planned enrollment, is one of 2 that started in 2026, is one of 14 in phase 2, reaches primary completion later than 12 of the 14 other live ones, and was the 23rd registered.
676 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.
Browse Esophageal Squamous Cell Carcinoma studies →13 of the 23 studies testing tislelizumab in Esophageal Squamous Cell Carcinoma are open now, in 4 countries. Recruiting first, the newest first:
BeOne Medicines · Sites in United States
Ages 18+
Ming-Yu Lien · Sites in Taiwan
Ages 20+
Shanghai Zhongshan Hospital · Sites in China
Ages 18+
Sichuan University · Sites in China
Ages 18–75
Guo Xufeng · Sites in China
Ages 18–75
By country, each count listing its studies:
tislelizumab: first FDA approval 2024 (TEVIMBRA), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 180 Esophageal Squamous Cell Carcinoma studies recruiting now, 83 (46%) set no upper age limit and 76 (42%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 17 · Phase 3 4 · Phase 4 1
First in 2018; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 64 across 563 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Median enrollment 50 across the 23 interventional studies. Of the 6 that completed or were terminated, 5 (83%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 23 have an industry lead sponsor. The 10 most frequent:
BeOne Medicines is the lead sponsor of 69 studies on the registry; 49 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
10 studies in Esophageal Squamous Cell Carcinoma by BeOne Medicines: 2 open now, 2 under way, none of them phase 3. Of 8 finished, 6 (75%) have results posted.
Among the 10 studies in Esophageal Squamous Cell Carcinoma by BeOne Medicines, this one is the 8th largest by planned enrollment, is one of 2 that started in 2026, is one of 7 in phase 2, and was the 10th registered.
BeOne Medicines’s Esophageal Squamous Cell Carcinoma studies by the year they started, since 2017.
1 of the studies testing tislelizumab in Esophageal Squamous Cell Carcinoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07317609Shanghai Zhongshan HospitalNeoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02) | 2027-09-30 |
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Among the 23 studies testing tislelizumab in Esophageal Squamous Cell Carcinoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among BeOne Medicines’s 10 in Esophageal Squamous Cell Carcinoma:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Serum Concentrations of Tislelizumab at Specified Time Points
Time frame: 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
Time frame: 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
Time frame: Approximately 12 months
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
Time frame: 6 months
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Feb 2028, 17 months after the start.
Of 173 phase 2 interventional studies under Esophageal Squamous Cell Carcinoma, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 52. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Tislelizumab
Esophageal Squamous Cell Carcinoma →