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Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04974047
Recruitment Status : Active, not recruiting
First Posted : July 23, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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
Resectable Esophageal Squamous Cell Carcinoma Drug: Tislelizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 17, 2021
Estimated Primary Completion Date : April 17, 2023
Estimated Study Completion Date : May 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: BGB-A317
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 Name: BGB-A317


Outcome Measures
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Primary Outcome Measures :
  1. pCR Rate [ Time Frame: 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 :
  1. R0 Resection Rate [ Time Frame: approximately 5 years ]
    This will be defined as the proportion of participants with R0 resection.

  2. 1-year/3-year Disease-free Survival (DFS) Rate [ Time Frame: 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 (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.

  3. 1-year/3-year Event-free Survival (EFS) Rate [ Time Frame: approximately 5 years ]
    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.

  4. Objective Response Rate (ORR) [ Time Frame: 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.

  5. Number Of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: approximately 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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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): NCT04974047


Locations
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China, Anhui
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
China, Hebei
The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
Shijia Zhuang, Hebei, China
China, Hubei
Union Hospital Tongji Medical College HuaZhong University of Science and Technology
Wuhan, Hubei, China, 430022
China, Shanghai
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai, China
China, Shanxi
Tangdu Hospital
Xi'an, Shanxi, China
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610017
China, Tianjin
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04974047    
Other Study ID Numbers: BGB-A317-213
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Keywords provided by BeiGene:
Tislelizumab
PET
Chemotherapy
Chemoradiotherapy
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
Tislelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents