Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)

Official Title
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Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

Conditions
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Immunotherapy Esophagus Cancer

Intervention / Treatment
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* Drug: Tislelizumab
* Drug: Albumin paclitaxel
* Drug: Nedaplatin
* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);; Aged 18-70, both sexes; ECOG score 0-1 The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1; Adequate organ and bone marrow function, meeting the following definitions: Blood routine (no blood transfusion, no granulocyte colony-stimulating factor [G-CSF], and no other drugs were used within 14 days before treatment);Absolute neutrophil count (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥100×109/L; Blood biochemistry Creatinine clearance rate ≥60 mL/min;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN; Expected survival time > 6 months; Fertile female subjects and male subjects with partners of reproductive age are required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last treatment; Patients who volunteered to participate in this study and signed the informed consent form. Exclusion Criteria: A history of fistula caused by primary tumor invasion; Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization); Known intolerance or resistance to chemotherapy specified in the trial protocol; have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy); Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis and acute lung disease; Severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment; Known history of HIV infection; Other malignancies (except cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix) in the past 5 years; Received live vaccine within 28 days before enrollment; while participating in another therapeutic clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tislelizumab combined with chemothapy<br> | Drug: Tislelizumab<br>* Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks<br>Drug: Albumin paclitaxel<br>* Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks<br>Drug: Nedaplatin<br>* Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks<br>Radiation: radiotherapy<br>* 50-60Gy/25-30f<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | Time from enrollment to the onset of disease progression or death | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor | every 6 weeks （up to 24 months） | 
| Overall survival (OS) | Defined from date of Signing ICF to date of first documentation of death from any cause or censored at the date of the last follow-up. | every 3 months (up to 24 months) |