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

Official title

Tislelizumab Combined With Chemotherapy for the Perioperative Treatment of Esophageal Squamous Carcinoma： Single-arm Clinical Phase II Study

Overview

Evaluating the rate of pathologic complete remission in patients with squamous esophageal cancer treated perioperatively with tislelizumab in combination with chemotherapy

Interventions

• Drug Tislelizumab
  Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
• Drug albumin-bound paclitaxel
  albumin-bound paclitaxel 260mg/m2，day 1 of every 3 weeks
• Drug Nedaplatin
  Nedaplatin 80mg/m2，day 1 of every 3 weeks

Primary outcome measures

• Pathological complete response rate [Time frame: 4 weeks after surgery]

Secondary outcome measures (2)

• Major pathological response rate [Time frame: 4 weeks after surgery]
• Objective Response Rate [Time frame: At the end of Cycle 2(each cycle is 28 days)]

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.

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07019181 · SL-2024KY088-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗