Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC
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| ClinicalTrials.gov Identifier: NCT03957590 |
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Recruitment Status :
Active, not recruiting
First Posted : May 21, 2019
Last Update Posted : March 2, 2022
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Sponsor:
BeiGene
Information provided by (Responsible Party):
BeiGene
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) | Drug: Tislelizumab Drug: Placebo Drug: Paclitaxel Drug: Cisplatin Radiation: Radiotherapy | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 370 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 12, 2019 |
| Actual Primary Completion Date : | May 27, 2021 |
| Estimated Study Completion Date : | October 30, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Tislelizumab + chemoradiotherapy
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
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Drug: Tislelizumab
Administrated at dose of 200 mg intravenously (IV)
Other Name: BGB-A317 Drug: Paclitaxel Administered as 135 mg/m² IV injection Drug: Cisplatin Administered as 25 mg/m² IV injection Radiation: Radiotherapy Administered at a total dose of 50.4 Gy in 28 fractions |
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Placebo Comparator: Placebo combined + chemoradiotherapy
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
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Drug: Placebo
Placebo to match tislelizumab Drug: Paclitaxel Administered as 135 mg/m² IV injection Drug: Cisplatin Administered as 25 mg/m² IV injection Radiation: Radiotherapy Administered at a total dose of 50.4 Gy in 28 fractions |
Primary Outcome Measures :
- Progression-free survival (PFS) [ Time Frame: From date of randomization up to 4 years, approximately ]
Secondary Outcome Measures :
- overall response rate (ORR) [ Time Frame: From date of randomization up to 4 years, approximately ]
- duration of response (DOR) [ Time Frame: From first determination of an objective response up to 4 years, approximately ]
- overall survival (OS) [ Time Frame: From date of randomization up to 4 years, approximately ]
- change from baseline in European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30). [ Time Frame: From date of randomization to end of treatment ~2 years, ]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.
- change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer module (EORTC QLQ-OES18). [ Time Frame: From date of randomization to end of treatment, ~2years ]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 .
- The incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events'. [ Time Frame: From date of enrollment up to 4 years, approximately. ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957590
Locations
Show 32 study locations
Sponsors and Collaborators
BeiGene
Investigators
| Principal Investigator: | Weihu Wang, MD | Peking University Cancer Hospital & Institute | |
| Principal Investigator: | Zefen Xiao, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | BeiGene |
| ClinicalTrials.gov Identifier: | NCT03957590 |
| Other Study ID Numbers: |
BGB-A317-311 CTR20190198 ( Registry Identifier: Center for drug evaluation, CFDA ) |
| First Posted: | May 21, 2019 Key Record Dates |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Paclitaxel Cisplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |