Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squ… (NCT07039162) | Clinical Trial Compass
RecruitingPhase 2
Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma
Taiwan45 participantsStarted 2025-09-26
Plain-language summary
This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery.
The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Patients had histologically confirmed, squamous-cell carcinoma of the esophagus
✓. Clinical T4 cancer, at least one unresectable metastatic regional lymph node due to invasion into an adjacent organ, or computed tomographic (CT) evidence of M1Lym, such as fixed supraclavicular nodes. Regional lymph nodes are defined on the basis of criteria specified by the eighth edition of the Union for International Cancer Control TNM staging system (Sobin and Wittekind, 2016).
✓. An age of at least 20 years
✓. An Eastern Cooperative Oncology Group performance-status score 0 or 1
✓. Adequate major organ functions
✓. Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time of informed consent until 5 months or more after the last dose of investigational products. (Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for ≥12 consecutive months without specific reasons.)
✓. Men must agree to use contraception from the start of study treatment until 3 months or more after the last dose of the investigational product.
What they're measuring
1
2-year OS rate
Timeframe: From the date of first treatment (induction chemoradiotherapy) to 2 years after treatment initiation.
✓. Patients must be willing to undergo definitive resection with lymph node dissection
Exclusion criteria
✕. Patient has received systemic therapy for advanced ESCC.
✕. Patients had distant metastasis, including liver, lung, bone and brain metastases.
✕. Patients had esophageal perforation or esophageal fistula
✕. Patients had tumor bleeding
✕. Patients had active infection(e.g. tuberculosis).
✕. History or known human immunodeficiency virus.
✕. Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
✕. Systemic immunosuppression therapy or chronic systemic steroid therapy (more than 10mg daily of prednisolone)