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

• Status: Not yet recruiting
• Trial end date: 2025-08-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fuzhou General Hospital
• Treatments: Nedaplatin; Paclitaxel

Criteria

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:

1. 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;

2. 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.