The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.
This study enrolled participants with esophageal squamous cell carcinoma who were eligible to have their tumor removed by surgery (also called surgical resection). The treatment phase of the study included the following: * Induction therapy, in which participants received 1 cycle of chemotherapy; * Neoadjuvant therapy (neoadjuvant refers to treatment that occurs before surgery, which can make the tumor easier to remove). In this study participants received neoadjuvant therapy based on their response to induction therapy. Response to induction therapy was assessed using the maximum standardized uptake value (SUVmax) measured using a Positron Emission Tomography (PET) scan. The SUV number refers to the level of brightness on the PET scan which reflects metabolic activity; increased metabolic activity can indicate cancerous growth. * Participants with a decrease in SUVmax of 35% or more after induction therapy received neoadjuvant treatment with tislelizumab plus chemotherapy. * Participants with a decrease in SUVmax less than 35% after induction therapy received neoadjuvant treatment with tislelizumab plus chemotherapy and radiotherapy. * Surgery to remove the remaining tumor (resection) was to occur 4-6 weeks after completion of neoadjuvant treatment. After surgery participants were followed until death, lost to follow-up, withdrawal of consent, or until the study was completed
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Administered intravenously on Day 1 of each 21-Day Cycle.
135 mg/m\^2 administered intravenously on Day 1 of each 21-Day Cycle.
80 mg/m\^2 administered intravenously on Day 1 of each 21-Day Cycle.
Anhui Provincial Hospital
Hefei, Anhui, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Pathological Complete Response (pCR) Rate
The pCR rate was defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. pCR rates were assessed by a pathologist at each site.
Time frame: pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86
R0 Resection Rate
Defined as the percentage of participants with R0 resection. R0 resection refers to a surgical procedure where the entire tumor is completely removed with no evidence of residual cancer tissue at the surgical margins.
Time frame: Resection was planned to occur 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86
1-year/3-year Disease-free Survival (DFS) Rate
The DFS rate is defined as the percentage of participants free from disease events at 1 year and 3 years after the first date of no disease (R0 resection as surgery outcome). Disease events include local or distant recurrence or death due to any cause. The DFS rate was analyzed only for participants who underwent R0 resection. Disease-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula.
Time frame: 1 year and 3 years after surgery
1-year/3-year Event-free Survival (EFS) Rate
The EFS rate is defined as the percentage of participants free from EFS events at 1 year and 3 years after the first dose. The EFS events include progression of disease that precludes definitive surgery, local or distant recurrence, or death due to any cause. Event-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula.
Time frame: 1 year and 3 years after first dose date
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1000 mg/m\^2 administered intravenously over Day 1 through 4 of each 21-Day Cycle.
40 grays/20 fractions
Performed as indicated in the treatment arm.
Wuhan, Hubei, China
Tangdu Hospital
Xi'an, Shaanxi, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants who have a complete response or partial response before surgery as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in all participants with measurable disease at baseline. Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) of the neck, chest, and abdomen. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: ORR was assessed prior to surgery, Day 71 to 86
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab
Time frame: From the first dose of study drug up to 30 days after last dose of any component of treatment or surgery or the initiation of subsequent anticancer therapy, whichever occurred first. Up to approximately 9 months.