Clinical trial NCT04974047: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Resectable Esophageal Squamous Cell Carcinoma
Keywords: Tislelizumab
PET
Chemotherapy
Chemoradiotherapy
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: pCR Rate
timeFrame: approximately 5 years
Secondary outcomes:
measure: R0 Resection Rate
timeFrame: approximately 5 years
measure: 1-year/3-year Disease-free Survival (DFS) Rate
timeFrame: approximately 5 years
measure: 1-year/3-year Event-free Survival (EFS) Rate
timeFrame: approximately 5 years
measure: Objective Response Rate (ORR)
timeFrame: approximately 5 years
measure: Number Of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: approximately 5 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Xian
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Affiliated Zhongshan Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: