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

NCT07019181 | Not Yet Recruiting Phase 2

• 1 other identifier: SL-2024KY088-01
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  Pathological complete responseTotal tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

  4 weeks after surgery

Secondary Outcomes (2)

• Major pathological response rate

  4 weeks after surgery

• Objective Response Rate

  At the end of Cycle 2(each cycle is 28 days)

Study Arms (1)

Tislelizumab combined with chemotherapy

EXPERIMENTAL

Drug: Tislelizumab; Drug: albumin-bound paclitaxel; Drug: Nedaplatin

Interventions

Tislelizumab DRUG

Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

Tislelizumab combined with chemotherapy

albumin-bound paclitaxel DRUG

albumin-bound paclitaxel 260mg/m2，day 1 of every 3 weeks

Tislelizumab combined with chemotherapy

Nedaplatin DRUG

Nedaplatin 80mg/m2，day 1 of every 3 weeks

Tislelizumab combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

tislelizumab; Albumin-Bound Paclitaxel; nedaplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Geng guo jun, Doctor

CONTACT

13365922380; ggj622@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 13, 2025
• Study Start: July 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-05