Clinical Trials List
2024-06-30 - 2029-06-30
Phase II
Recruiting8
ICD-10C15.9
Malignant neoplasm of esophagus, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9150.9
Malignant neoplasm of esophagus, unspecified
Phase II Study of Tislelizumab Combined With Induction Chemoradiotherapy and Subsequent Conversion Surgery for Locally Advanced Unresectable ESCC
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Trial Applicant
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2026/06/17
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Chi Lin
- JHE-CYUAN GUO 無
- 莊建淮
- TA-CHEN HUANG 無
- 郭弘揚 無
- JANG-MING LEE 無
- 陳柏邑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 姜乃榕 無
- 唐振育 無
- Tien-Hua Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉奕廷
- Wei-Lun Chang Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Chih-Chieh Yen
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution 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
WBC ≥3,500/mm3
Hemoglobin ≥ 9.0 g/dL
Platelet ≥ 80,000/mm3
Total bilirubin ≤ 2-fold the upper limit of normal (ULN)
ALT and AST ≤ 5-fold the ULN AND ≤200 U/L
PT, aPTT and INR ≤1.5-fold the ULN
Albumin ≥2.5 g/dL
Creatinine clearance ≥50 ml/min (based upon 24 hours urine collection or calculated by Cockroft-Gault formula)
Male: ((140 - age) × weight [kg])/(72 × serum creatinine [mg/dL])
Female: 0.85 x estimate for male
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.
Patients must be willing to undergo definitive resection with lymph node dissection
Participants must have signed written informed consent form in accordance with regulatory and institutional guidelines.
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)
Known hepatitis B (HBsAg reactive) or C virus infection (positive anti HCV)
Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL or < 2500 copies/mL) can be enrolled. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for > 2 weeks before randomization/enrollment.
Patients with a positive HCV antibody test followed by a negative HCV RNA test at screening are eligible.
Previous therapy targeting T-cell costimulating or immune-checkpoint pathways
Prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
Any major surgery within 4 weeks before study enrollment.
Pregnant women or nursing mothers, or positive pregnancy tests
Patients had allogeneic stem cell transplantation or organ transplantation.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
Patients with interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Other patients judged by the investigators be inappropriate as subjects of this study
The Estimated Number of Participants
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Taiwan
45 participants
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Global
45 participants
