Trial Title:
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06010303
Condition:
Esophageal Cancer
Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LBL-007
Description:
LBL-007 will be administered at a standard dose intravenously.
Arm group label:
LBL-007
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab will be administered at a standard dose intravenously.
Arm group label:
LBL-007
Arm group label:
Tislelizumab and Chemotherapy
Other name:
BGB-A317
Intervention type:
Drug
Intervention name:
Chemotherapy Doublet
Description:
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.
Arm group label:
LBL-007
Arm group label:
Tislelizumab and Chemotherapy
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230000
Country:
China
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Facility:
Name:
The Tumor Hospital Affiliated to Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Facility:
Name:
Anyang Cancer Hospital
Address:
City:
Anyang
Zip:
455001
Country:
China
Facility:
Name:
Nanyang Central Hospital
Address:
City:
Nanyang
Zip:
473000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xinxiang Medical University
Address:
City:
Xinxiang
Zip:
453100
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Facility:
Name:
The First Peoples Hospital of Changzhou
Address:
City:
Changzhou
Zip:
213000
Country:
China
Facility:
Name:
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Address:
City:
Nanjing
Zip:
210008
Country:
China
Facility:
Name:
Nantong Tumor Hospital Branch North
Address:
City:
Nantong
Zip:
226000
Country:
China
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Zip:
221000
Country:
China
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Shandong First Medical University
Address:
City:
Taian
Zip:
271099
Country:
China
Facility:
Name:
Sichuan Cancer Hospital and Institute
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Address:
City:
Chengdu
Zip:
610071
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Facility:
Name:
National Cancer Center
Address:
City:
Goyangsi
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
HwasunGun
Zip:
58128
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
The Catholic University of Korea, Seoul St Marys Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Facility:
Name:
Changhua Christian Hospital
Address:
City:
Changhua
Zip:
50006
Country:
Taiwan
Facility:
Name:
Kaohsiung Medical University Chung Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10048
Country:
Taiwan
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Facility:
Name:
Ramathibodi Hospital Mahidol University
Address:
City:
Bangkok
Zip:
10400
Country:
Thailand
Facility:
Name:
Siriraj Hospital
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Facility:
Name:
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Address:
City:
Ongkharak
Zip:
26120
Country:
Thailand
Facility:
Name:
Phramongkutklao Hospital
Address:
City:
Ratchathewi
Zip:
10400
Country:
Thailand
Start date:
November 8, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010303
