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A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

NCT03430843•BeiGene

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
•2. Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
•3. At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

Exclusion Criteria

•1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
•2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
•3. Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
•4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
•5. Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
•6. Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
•7. Active brain or leptomeningeal metastasis.
•8. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
•9. Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
•10. Known history of Human Immunodeficiency Virus (HIV)
+2 more criteria

Locations (104)

Henry Ford Hospital

Detroit, Michigan, United States

Toledo Clinic Cancer Center

Toledo, Ohio, United States

Imelda Ziekenhuis Bonheiden

Bonheiden, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

Uz Antwerpen

Edegem, Belgium

University Hospitals Leuven

Leuven, Belgium

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

January 26, 2018

Primary Completion Date

December 1, 2020

Completion Date

December 28, 2022

Last Updated

October 26, 2024

Enrollment

512

ACTUAL participants

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Tislelizumab

DRUG

Paclitaxel

DRUG

Docetaxel

DRUG

Irinotecan

DRUG

MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma

NCT07359417

Esophageal Squamous Cell Carcinoma (ESCC)Esophageal Cancer, Squamous Cell

View study

RECRUITINGPHASE1/PHASE2

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

NCT05473156

Locally Advanced or Metastatic Solid TumorsNon Small Cell Lung Cancer (NSCLC)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

Tumor Regression Grade As Predictor of Adjuvant Therapy

A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)

Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy

Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma