Actively Recruiting
Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma
Led by Guo Xufeng · Updated on 2023-09-28
73
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to analyze esophageal cancer patients who underwent neoadjuvant immunotherapy with chemotherapy followed by esophagectomy to determine whether additional adjuvant therapy is associated with improved survival outcomes.
CONDITIONS
Official Title
Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who volunteer, sign consent, comply with follow-up, and can follow the study protocol
- Histologically confirmed squamous cell carcinoma of the thoracic esophagus
- No prior systemic or local treatment for esophageal cancer
- Clinical stage cT1b-3N1-3M0 or T3N0M0 based on AJCC/UICC 8th edition
- Male or female aged 18 to 75 years
- ECOG performance status 0 or 1
- Expected to achieve R0 tumor resection
- Adequate cardiac function including ECG and, if needed, echocardiography with LVEF >50%
- Adequate respiratory function with FEV1 ≥1.2 L, FEV1% ≥50%, and DLCO ≥50%
- Adequate bone marrow function: WBC >4×10⁹/L, neutrophils >1.5×10⁹/L, hemoglobin >90 g/L, platelets >100×10⁹/L
- Liver function: AST and ALT ≤3× upper limit of normal (ULN); total bilirubin <1.5× ULN
- Adequate renal function: GFR >60 mL/min; serum creatinine ≤120 µmol/L
- Fertile females must have negative pregnancy test within 72 hours before treatment and use effective contraception during and 3 months after the study; males with partners of reproductive age must use effective contraception during and 3 months after the study
You will not qualify if you...
- Factors making tumor unresectable or contraindications to surgery, or refusal of surgery
- Supraclavicular lymph node metastasis
- Poor nutritional status with BMI <18.5 kg/m² unless corrected before enrollment
- Allergy to any study drugs
- Previous or current treatment with radiotherapy, chemotherapy, immunosuppressive drugs (>10 mg/day prednisone or equivalent) within 2 weeks before study drug, live attenuated vaccine within 4 weeks, or major surgery/severe trauma within 4 weeks before study drug
- Active infection with HIV, hepatitis B or C, or known seropositivity
- Uncontrolled cardiac symptoms or diseases including heart failure >NYHA class II, unstable angina, recent myocardial infarction, or uncontrolled arrhythmias
- Severe infection (CTCAE >2) within 4 weeks before study drug
- Participation in other drug trials within 4 weeks before randomization
- Interstitial pneumonia, lung disease, pulmonary fibrosis, active pneumonia, or severe lung function impairment
- Active or history of autoimmune diseases requiring systemic treatment, except controlled hypothyroidism or diabetes; asthma requiring bronchodilators excluded
- Previous treatment with anti-PD-1, PD-L1, or other checkpoint inhibitors
- Other cancers diagnosed within 5 years except low-risk treated skin or cervical cancers
- Pregnant or breastfeeding women
- Other serious medical conditions, mental illness, substance abuse, or social factors affecting safety or adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai chest hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xufeng Guo, PH.D
CONTACT
X
Xufeng Guo, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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