A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

Phase 3

Completed

• Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
• Interventions: Drug: Tislelizumab; Drug: Placebo; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy

• Registration Number: NCT03957590
• Lead Sponsor: BeiGene

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Study Start: 2019-06-12
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo combined + chemoradiotherapy	Cisplatin	Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy
Placebo combined + chemoradiotherapy	Radiotherapy	Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy
Tislelizumab + chemoradiotherapy	Tislelizumab	Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy
Tislelizumab + chemoradiotherapy	Paclitaxel	Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy
Tislelizumab + chemoradiotherapy	Cisplatin	Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy
Tislelizumab + chemoradiotherapy	Radiotherapy	Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy
Placebo combined + chemoradiotherapy	Placebo	Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy
Placebo combined + chemoradiotherapy	Paclitaxel	Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From date of randomization up to 4 years, approximately	PFS is- defined as the time from randomization to the first documented disease progression, as determined by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	From date of randomization up to 4 years, approximately	OS is defined as the time from the date of randomization to the date of death due to any cause.
Change from baseline in European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30)	Baseline to end of treatment ~2 years	The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer module (EORTC QLQ-OES18)	Up to 2 years, approximately	Total of 18 questions to assess your symptoms or problems during the past week, each assessed on a scale from 1 (not at all) to 4 (very much). with the range from minimum scores 1 as better outcome and maximum 4 as worst outcomes. Symptoms includes whether any difficulty to eating solids, liquidized or softs food, drinking, or not， whether it is difficult to or swallowing, trouble eating or enjoying meals, pain when eating, dry mouth, food tasting differently, trouble talking, ， 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 in the chest or stomach.
Overall response rate (ORR)	From date of randomization up to 4 years, approximately	ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by BIRC per RECIST v1.1
Duration of response (DOR)	From first determination of an objective response up to 4 years, approximately	DOR is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the BIRC per RECIST v1.1, or death from any cause, whichever occurs first
Number of Participants with treatment-emergent adverse events (TEAEs)	Up to 2 years, approximately	Adverse events will be graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events

Trial Locations

Locations (33)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

The First Affiliated Hospitalschool of Clinical Medicine of Guangdong Pharmaceutical University; 🇨🇳 Guangzhou, Guangdong, China

Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University ); 🇨🇳 Jieyang, Guangdong, China

Changzhou Tumor(Fourth Peoples)Hospital; 🇨🇳 Changzhou, Jiangsu, China

The First Peoples Hospital of Lianyungang; 🇨🇳 Lianyungang, Jiangsu, China

Northern Jiangsu Peoples Hospital; 🇨🇳 Yangzhou, Jiangsu, China

Liaoning Cancer Hospital and Institute; 🇨🇳 Shenyang, Liaoning, China

The First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xian, Shaanxi, China

Weifang Peoples Hospital; 🇨🇳 Weifang, Shandong, China

Sichuan Cancer Hospital and Institute; 🇨🇳 Chengdu, Sichuan, China

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