Tislelizumab Combined With Chemotherapy for the Perioperative Treatment of Esophageal Squamous Carcinoma

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called tislelizumab combined with chemotherapy to treat patients with a specific type of esophagus cancer known as squamous esophageal carcinoma. The goal is to see how effective this treatment is in helping patients achieve a complete response, meaning no signs of cancer after treatment. The trial is currently not recruiting participants, but it aims to include adults aged 18 to 75 who have been diagnosed with this type of cancer and meet certain health criteria.

To be eligible for this trial, participants must have a specific stage of esophageal cancer and normal functioning of major organs. They also need to be able to provide informed consent and have an expected survival of more than six months. Participants can expect to receive the combination treatment and will be closely monitored throughout the study to assess how well the treatment works. It’s important to note that individuals with certain health conditions, such as uncontrolled systemic diseases or a history of severe infections, may not be suitable for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects were enrolled in the study and signed an informed consent form.
• • Male or female patients between the ages of 18 and 75.
• • Patients with esophageal squamous carcinoma diagnosed by histopathology.
• • According to the TNM staging system of esophageal cancer in the 8th edition of the AJCC,the disease is in the stage of cT3-4aN0M0 or cT1b-4aN+M0 (confirmed by thoracic and abdominal enhancement CT/MRI), and the lesion is located in the thoracic segment.
• • ECOG score: 0-1.
• • Normal functioning of major organs, i.e. meeting the following criteria.
• • 1. Blood count (no blood transfusions, granulocyte colony-stimulating factor \[G-CSF\], or other medications corrected within 14 days prior to treatment); and Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HB) ≥9.0 g/dL; and Platelet count (PLT) ≥ 100 x 109/L;
• • 2. blood biochemistry Creatinine clearance ≥60 mL/min. Total bilirubin (TBIL) ≤ 1.5 x ULN. Albuminous aminotransferase (AST) or albuminous aminotransferase (ALT) levels ≤ 2.5 x ULN;
• • Expected survival \> 6 months.
• • Female subjects of childbearing potential and male subjects with partners of childbearing potential are required to use a medically approved contraceptive method during study treatment and for at least 6 months after the last treatment.
• Exclusion Criteria:
• • The presence of clinically uncontrolled chest that required repeated drainage or medical intervention (within 2 weeks prior to randomization) Hydrocele, pericardial hydrocele or ascites;
• • Known intolerance or resistance to chemotherapy specified in the trial protocol;
• • Have received any other ESCC anti-tumor therapy (e.g., targeting PD-1, PD-L1, PD-L2) Or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor therapy);
• • Patients who have an active autoimmune disease or have a history of an autoimmune disease but may relapse may have a known abnormality History of body organ transplantation or allogeneic hematopoietic stem cell transplantation;
• • A history of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease, including pulmonary fibrosis, Acute lung disease;
• • There were severe chronic or active patients requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment Infection (including tuberculosis infection, etc.);
• • Have a known history of HIV infection;
• * The presence of any serious or uncontrolled systemic disease, including but not limited to:
• • Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure; Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, cerebrovascular accident, or transient ischemic attack, during the 6 months prior to the first dose of the study; Uncontrolled hypertension (i.e., ≥ CTC-AE level 2 hypertension after medication); active pulmonary tuberculosis; those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
• • Had other malignancies in the past 5 years (cured skin basal cell carcinoma, breast carcinoma in situ and Except primary cervical cancer);
• • Had received live vaccine within 28 days prior to enrollment;
• • Have participated in other therapeutic clinical trials within 4 weeks;
• • And those deemed unsuitable for inclusion by the researchers.