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

Phase 2

Not yet recruiting

• Conditions: Esophagus Cancer
• Interventions: Drug: Tislelizumab; Drug: albumin-bound paclitaxel; Drug: Nedaplatin

• Registration Number: NCT07019181
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-07-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab combined with chemotherapy	Tislelizumab	-
Tislelizumab combined with chemotherapy	albumin-bound paclitaxel	-
Tislelizumab combined with chemotherapy	Nedaplatin	-

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate	4 weeks after surgery	Pathological complete responseTotal tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

Secondary Outcome Measures

Name	Time	Method
Major pathological response rate	4 weeks after surgery	Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Objective Response Rate	At the end of Cycle 2(each cycle is 28 days)	Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor