Back to resultsStudy of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
Primary Purpose
Resectable Esophageal Squamous Cell Carcinoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Resectable Esophageal Squamous Cell Carcinoma focused on measuring Tislelizumab, PET, Chemotherapy, Chemoradiotherapy
Eligibility Criteria
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Histologically confirmed esophageal squamous cell carcinoma (ESCC).
- Stage cT1-2N+M0 and cT3NanyM0 (per The American Joint Committee on Cancer 8th Edition).
- Evaluation by the investigator to confirm eligibility for an R0 resection with curative intent.
- Adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose.
Key Exclusion Criteria:
- Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy.
- Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, targeted therapy agents, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting T-Cell co-stimulation or checkpoint pathways.
- History of fistula due to primary tumor invasion.
- Participants with high risk of fistula or sign of perforation evaluated by investigator.
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.
* Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
* Controlled Type I diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection.
- Severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Anhui Provincial Hospital
- Fujian Medical University Union Hospital
- The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
- Union Hospital Tongji Medical College HuaZhong University of Science and Technology
- Affiliated Zhongshan Hospital of Fudan University
- Tangdu Hospital
- West China Hospital of Sichuan University
- Tianjin Medical University Cancer Institute & Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort A (Responder)
Cohort B (Non-responder)
Arm Description
Participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% will receive 3 cycles of tislelizumab (200 milligrams [mg]/cycle) plus 2 cycles of chemotherapy doublet (cisplatin + paclitaxel)
Participants with a decrease in PET SUVmax < 35% will receive 3 cycles of tislelizumab (200 mg/cycle) plus 2 cycles of investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) plus concurrent radiotherapy (40 grays/20 fractions).
Outcomes
Primary Outcome Measures
pCR Rate
The pCR will be defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment.
Secondary Outcome Measures
R0 Resection Rate
This will be defined as the proportion of participants with R0 resection.
1-year/3-year Disease-free Survival (DFS) Rate
The DFS will be defined as the proportion of participants free from disease events at 1st year and 3rd year after the first date of no disease. The DFS will be defined as the time from the first date of no disease (R0 resection as surgery outcome) to local or distant recurrence or death due to any cause, whichever occurs first. The DFS rate will be analyzed only for participants who undergo R0 resection.
1-year/3-year Event-free Survival (EFS) Rate
The EFS will be defined as the proportion of participants free from EFS events at 1st year and 3rd year after the first dose. The EFS will be defined as the time from the time of first dose until any of the following events, whichever occurs first: progression of disease that precludes definitive surgery, local or distant recurrence, or death due to any cause.
Objective Response Rate (ORR)
The ORR will be defined as the proportion of participants who have a complete response or partial response before surgery as assessed by the investigator per RECIST v1.1 in all participants with measurable disease at baseline.
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04974047
Brief Title
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
Official Title
A Phase 2, Multicenter, Open-label, 2-Cohort Study to Investigate the Efficacy and Safety of PET Guided Neoadjuvant Treatment With Tislelizumab (BGB-A317) Plus Chemotherapy/Chemoradiotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
May 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Esophageal Squamous Cell Carcinoma
Keywords
Tislelizumab, PET, Chemotherapy, Chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A (Responder)
Arm Type
Experimental
Arm Description
Participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% will receive 3 cycles of tislelizumab (200 milligrams [mg]/cycle) plus 2 cycles of chemotherapy doublet (cisplatin + paclitaxel)
Arm Title
Cohort B (Non-responder)
Arm Type
Experimental
Arm Description
Participants with a decrease in PET SUVmax < 35% will receive 3 cycles of tislelizumab (200 mg/cycle) plus 2 cycles of investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) plus concurrent radiotherapy (40 grays/20 fractions).
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Administered intravenously as specified in the treatment arm.
Primary Outcome Measure Information:
Title
pCR Rate
Description
The pCR will be defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment.
Time Frame
approximately 5 years
Secondary Outcome Measure Information:
Title
R0 Resection Rate
Description
This will be defined as the proportion of participants with R0 resection.
Time Frame
approximately 5 years
Title
1-year/3-year Disease-free Survival (DFS) Rate
Description
The DFS will be defined as the proportion of participants free from disease events at 1st year and 3rd year after the first date of no disease. The DFS will be defined as the time from the first date of no disease (R0 resection as surgery outcome) to local or distant recurrence or death due to any cause, whichever occurs first. The DFS rate will be analyzed only for participants who undergo R0 resection.
Time Frame
approximately 5 years
Title
1-year/3-year Event-free Survival (EFS) Rate
Description
The EFS will be defined as the proportion of participants free from EFS events at 1st year and 3rd year after the first dose. The EFS will be defined as the time from the time of first dose until any of the following events, whichever occurs first: progression of disease that precludes definitive surgery, local or distant recurrence, or death due to any cause.
Time Frame
approximately 5 years
Title
Objective Response Rate (ORR)
Description
The ORR will be defined as the proportion of participants who have a complete response or partial response before surgery as assessed by the investigator per RECIST v1.1 in all participants with measurable disease at baseline.
Time Frame
approximately 5 years
Title
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame
approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Histologically confirmed esophageal squamous cell carcinoma (ESCC).
Stage cT1-2N+M0 and cT3NanyM0 (per The American Joint Committee on Cancer 8th Edition).
Evaluation by the investigator to confirm eligibility for an R0 resection with curative intent.
Adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose.
Key Exclusion Criteria:
Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy.
Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, targeted therapy agents, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting T-Cell co-stimulation or checkpoint pathways.
History of fistula due to primary tumor invasion.
Participants with high risk of fistula or sign of perforation evaluated by investigator.
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.
* Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
* Controlled Type I diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection.
Severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
City
Shijia Zhuang
State/Province
Hebei
Country
China
Facility Name
Union Hospital Tongji Medical College HuaZhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Affiliated Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610017
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
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