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New treatment option for Esophageal Squamous Cell Carcinoma (ESCC)
Official title Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07039162
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma (escc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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)...
- An age of at least 20 years
- An Eastern Cooperative Oncology Group performance-status score 0 or 1
- Adequate major organ functions
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
- people with active, known, or suspected autoimmune disease. people with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as...
- 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 \ 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...
- 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 people of this study
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan; Taichung, Taiwan; Tainan, Taiwan; Taipei, Taiwan; Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.