Can a flexible dosing schedule improve esophageal cancer treatment?
NCT ID NCT07733180
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Osaka Keisatsu Hospital
RECRUITINGOsaka, 543-0042, Japan
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Other studies related to the condition(s) this trial covers.
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- New drug cocktail aims to fight tough esophageal cancer