CompletedPhase 2

A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

China, South Korea, Taiwan118 participantsStarted 2023-11-08

Plain-language summary

This is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to provide written informed consent and can agree to comply with the study requirements. * Participants with metastatic ESCC or unresectable, locally advanced ESCC. * Histologically confirmed diagnosis of ESCC. * Can provide a tumor sample. * At least 1 measurable lesion as defined by RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. Exclusion Criteria: * Prior treatment for advanced or metastatic ESCC within the past 6 months * Locally advanced ESCC that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator * Palliative radiation treatment for ESCC within the past 4 weeks * Participants with an esophageal/bronchial or esophageal/aorta fistula * Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Response Rate (ORR)

Timeframe: Approximately 10 months

Trial details

NCT IDNCT06010303

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-30

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