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Can a flexible dosing schedule improve esophageal cancer treatment?

NCT ID NCT07733180

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether giving the immunotherapy drug tislelizumab every 2 weeks or every 4 weeks, alongside standard chemotherapy, is safe and effective for Japanese patients with advanced esophageal cancer that cannot be removed by surgery. The study aims to find the best dosing schedule to control the disease and reduce side effects. All participants have not received prior treatment for their advanced cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tislelizumab plus chemotherapy (oxaliplatin, leucovorin, 5-fluorouracil)
What this could lead to
If successful, this could help identify a more convenient or effective dosing schedule for tislelizumab in treating advanced esophageal cancer.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply broadly. The combination therapy may cause significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Osaka Keisatsu Hospital

    RECRUITING

    Osaka, 543-0042, Japan

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