Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Tislelizumab

Fluorouracil

Albumin-Bound Paclitaxel

Cisplatin

Antineoplastic Agents, Immunological

LBL-007 in combination with tislelizumab plus chemotherapy doublet.

LBL-007 will be administered at a standard dose intravenously.

LBL-007

Tislelizumab will be administered at a standard dose intravenously.

Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel

Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.

Chemotherapy Doublet

Study Director

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).

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

A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.

Time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.

Time from the first determination of an overall response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.

Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.

Number of participants with AEs, including findings from physical examinations, electrocardiograms, and laboratory assessments according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma	NCT06010303	Esophageal Canc... Esophageal Squa... Esophageal Squa...	LBL-007 Tislelizumab Chemotherapy Do...	18 Years -	BeiGene
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma	NCT06010303	Esophageal Canc... Esophageal Squa... Esophageal Squa...	LBL-007 Tislelizumab Chemotherapy Do...	18 Years -	BeiGene

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