This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery. The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
1. ICRT phase -Tislelizumab and CRT regimen Tislelizumab 200 mg IV, C1D1 and C4D1 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. ) 3. Adjuvant phase-Tislelizumab Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of one year or 17 cycles.)
1. ICRT phase -Tislelizumab and CRT regimen Paclitaxel 50 mg/m2 IV, D1, weekly (\* 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Paclitaxel 135 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles.)
1. ICRT phase -Tislelizumab and CRT regimen Cisplatin 25 mg/m2 IV, D1, weekly ( 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Cisplatin 75 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. )
1\. ICRT phase -Tislelizumab and CRT regimen Radiotherapy treatment: IMRT 41-50.4Gy, a dose of 1.8 to 2Gy per day, 5 days per week for 5 weeks during the RT phase.
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
NOT_YET_RECRUITINGKaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
NOT_YET_RECRUITINGChina Medical University Hospital
Taichung, Taiwan
RECRUITINGTaichung Veterans General Hospital
Taichung, Taiwan
NOT_YET_RECRUITINGNational Cheng Kung University Hospital
Tainan, Taiwan
NOT_YET_RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
NOT_YET_RECRUITINGLinkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
NOT_YET_RECRUITING2-year OS rate
Estimated 2-year OS rate is defined as number of participants alive divided by the number of participants.
Time frame: From the date of first treatment (induction chemoradiotherapy) to 2 years after treatment initiation.
Pathological complete response (pCR) rate
Pathological complete response (pCR) rate is defined as number of participants with no evidence of residual tumor cells in the primary site and resected lymph nodes of the operative specimens divided by the number of participants received esophagectomy.
Time frame: At time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)
Conversion rate
Conversion rate is defined asnumber of participants received esophagectomy divided by the number of participants.
Time frame: Assessed within 12 weeks after completion of induction or consolidation treatment.
R0 resection rate
R0 resection rate is defined as the proportion of participants with negative resection margins (greater than 1 mm) among those who underwent esophagectomy following induction chemoradiotherapy and/or consolidation treatment with tislelizumab.
Time frame: Assessed at time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)
Disease-free survival (DFS)
Disease-free survival (DFS) is defined as the time from enrollment until evidence of disease recurrence or death.
Time frame: From enrollment until disease recurrence or death, whichever occurs first, assessed up to 2 years.
Event-free survival (EFS)
Event-free survival (EFS) is defined as the time from enrollment to an event which may include radiographic progression, clinical progression, 2nd aerodigestive tract squamous cell carcinoma, and death.
Time frame: From date of enrollment to first documented event or death, assessed up to 2 years.
Distant metastasis-free survival (DMFS)
Distant metastasis-free survival (DMFS) is defined as the time from enrollment until evidence of distant metastasis recurrence or death.
Time frame: From date of enrollment to first documented distant metastasis or death, assessed up to 2 years
Overall survival (OS)
Overall survival (OS) is defined as the time from enrollment to death
Time frame: From date of enrollment to death, assessed up to 2 years
Recurrence-free survival (RFS)
Recurrence-free survival (RFS) is Measure the length of time that patients remain free of disease recurrence or progression following initial treatment.
Time frame: From date of initial treatment to first documented recurrence or death, assessed up to 2 years
Adverse events
Adverse events related to protocol immunotherapy, chemotherapy, radiotherapy and conversion surgery .
Time frame: From the date of informed consent until the completion of study treatment and follow-up period, up to 2 years.
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