Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A (Responder) 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) |
Drug: Tislelizumab
Administered intravenously as specified in the treatment arm.
Other Names:
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| Experimental: Cohort B (Non-responder) 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). |
Drug: Tislelizumab
Administered intravenously as specified in the treatment arm.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- pCR Rate [approximately 5 years]
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
- Major Pathological Response (MPR) Rate [approximately 5 years]
The MPR will be defined as the proportion of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy.
- R0 Resection Rate [approximately 5 years]
This will be defined as the proportion of participants with R0 resection.
- 1-year/3-year Disease-free Survival (DFS) Rate [approximately 5 years]
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 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 [approximately 5 years]
The EFS will be defined as the proportion of participants free from progression events (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: radiographic disease progression as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause.
- Objective Response Rate (ORR) [approximately 5 years]
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 Adverse Events [approximately 5 years]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Eastern Cooperative Oncology Group Performance Status of 0 or 1.
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Histologically confirmed esophageal squamous cell carcinoma (ESCC).
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Stage cT1-2N+M0 and cT3NanyM0 (per The American Joint Committee on Cancer 8th Edition).
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Evaluation by the investigator to confirm eligibility for an R0 resection with curative intent.
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Adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose.
Key Exclusion Criteria:
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Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy.
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Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, 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.
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History of fistula due to primary tumor invasion.
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Participants with high risk of fistula or sign of perforation evaluated by investigator.
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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.
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History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
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With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection.
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Severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
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Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anhui Provincial Hospital | Hefei | Anhui | China | 230000 |
| 2 | Fujian Medical University Union Hospital | Fuzhou | Fujian | China | 350001 |
| 3 | The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital) | Shijia Zhuang | Hebei | China | |
| 4 | Union Hospital Tongji Medical College HuaZhong University of Science and Technology | Wuhan | Hubei | China | 430022 |
| 5 | Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai | China | |
| 6 | Tangdu Hospital | Xi'an | Shanxi | China | |
| 7 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610017 |
| 8 | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin | China |
Sponsors and Collaborators
- BeiGene
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BGB-A317-213