Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC

Esophageal Squamous Cell Carcinoma (ESCC) Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Localized Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03957590
• Other study ID #: BGB-A317-311
• Secondary ID: CTR20190198
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 12, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of BGB-A317 versus P placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 370
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• 18 to 75 years on the day of signing the informed consent form
• Histologically confirmed diagnosis of localized ESCC
• Measurable and/or non-measurable disease defined per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
• Adequate organ function

Key Exclusion Criteria:

• Indicators of severe malnutrition
• Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
• Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
• Received prior radiotherapy or therapies targeting PD-1, PD-L1, PD-L2 or other immune-oncology therapies
• Active autoimmune diseases or history of autoimmune diseases that may relapse NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tislelizumab
Administrated at dose of 200 mg intravenously (IV)
• Placebo
Placebo to match tislelizumab
• Paclitaxel
Administered as 135 mg/m² IV injection
• Cisplatin
Administered as 25 mg/m² IV injection

Radiation:
• Radiotherapy
Administered at a total dose of 50.4 Gy in 28 fractions

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Heping Hospital Affiliated to Changzhi Medical College	Changzhi
China	Changzhou Cancer Hospital	Changzhou
China	Sichuan Cancer hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin
China	Inner Mongolia Autonomous Region Cancer Hospital	Hohhot
China	Jieyang People's Hospital	Jieyang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jinhua Municipal Central Hospital	Jinhua
China	The First People's Hospital of Lianyungang	Lianyungang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	WeiFang People's Hospital	Weifang	Shandong
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Northern Jiangsu people's hospital	Yangzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		From date of randomization up to 4 years, approximately
Secondary	overall response rate (ORR)		From date of randomization up to 4 years, approximately
Secondary	duration of response (DOR)		From first determination of an objective response up to 4 years, approximately
Secondary	overall survival (OS)		From date of randomization up to 4 years, approximately
Secondary	change from baseline in European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30).	Scale consultant including to assess Global health status/Qol with range from minimum scores 1 as worse outcome and maximum scores 7 as higher values represent a better, Physical functioning, role functioning, Emotional functioning, Cognitive functioning, social functioning, fatigue, nausea and vomiting, pain dyspnoea, insomnia, appetite loss, constipation, diarrhea and finical difficulties with range from maximum scores 4 as worse outcome and from minimum scores 1 as higher values represent as better.	From date of randomization to end of treatment ~2 years,
Secondary	change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer module (EORTC QLQ-OES18).	Total 18 questions to assess your symptoms or problems during the past week with the range from minimum scores 1 as better outcome and maximum 4 as worst outcomes. includes whether any difficult to eat solids, liquids food or not, whether it is difficult to swallow , whether the sense of smell and conversation are normal or not, whether have Symptoms include cough, indigestion or heartburn, acid reflux and pain or not .	From date of randomization to end of treatment, ~2years
Secondary	The incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events'.		From date of enrollment up to 4 years, approximately.