Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma

Resectable Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04974047
• Other study ID #: BGB-A317-213
• Secondary ID: CTR20211753
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 17, 2021
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: May 30, 2026
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Resectable Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Tislelizumab
Administered intravenously as specified in the treatment arm.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Anhui Provincial Hospital	Hefei	Anhui
China	Affiliated Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)	Shijia Zhuang	Hebei
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Union Hospital Tongji Medical College HuaZhong University of Science and Technology	Wuhan	Hubei
China	Tangdu Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 5 years
Secondary	R0 Resection Rate	This will be defined as the proportion of participants with R0 resection.	approximately 5 years
Secondary	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.	approximately 5 years
Secondary	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.	approximately 5 years
Secondary	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.	approximately 5 years
Secondary	Number Of Participants Experiencing Treatment-Emergent Adverse Events		approximately 5 years