Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Ca… (NCT06056336) | Clinical Trial Compass
RecruitingPhase 2
Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma
China73 participantsStarted 2023-09-07
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study;
✓. Histologically-confirmed squamous cell carcinoma; tumors of the esophagus are located in the thoracic cavity;
✓. Have not received systemic and local treatment for esophageal cancer;
✓. Pre-treatment staging as cT1b-3N1-3M0 or T3N0M0, American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition;
✓. Male or female, aged ≥18 and ≤75 years;
✓. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0 -1;
✓. R0 resection is expected;
✓. Adequate cardiac function. All patients should perform electrocardiogram (ECG), and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \>50%;
Exclusion criteria
✕. Unresectable factors, including those who are unresectable for tumor reasons or have surgical contraindications, or who refuse surgery;
✕. Patients with supraclavicular lymph node metastasis;
✕. Poor nutritional status, BMI\<18.5Kg/m2; Patients could continue to be considered for enrollment if corrected with symptomatic nutritional support before enrollment and after assessment by the principal investigator
What they're measuring
1
2-year disease-free survival in non-pCR patients
Timeframe: Disease free survival time for recurrence or death within 2 years of surgery
✕. Have received or are receiving any of the following treatments; a) any radiotherapy, chemotherapy or other antineoplastic drugs directed at the tumour; b) being treated with an immunosuppressive drug or systemic hormone for immunosuppression (at a dose of \>10mg/ day of prednisone or equivalent) within 2 weeks before the first dose of the study drug; Inhaled or topical steroids and corticosteroid replacement at doses \>10mg/ day of prednisone or equivalent were allowed in the absence of active autoimmune disease; c) received live attenuated vaccine within 4 weeks before the first dose of study drug; d) major surgery or severe trauma within 4 weeks before the first dose of study drug;
✕. Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) active infection or known HIV seropositivity; including HBV or HCV surface antigen positive (RNA)
✕. Uncontrolled cardiac symptoms or diseases, including but not limited to: (1) heart failure above NYHA class II, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias without or poorly controlled after clinical intervention;
✕. Severe infection (CTCAE\>2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Prophylactic antibiotics were excluded if there was active pulmonary inflammation on chest imaging at baseline, if there were signs and symptoms of infection within 14 days before the first dose of the study drug, or if treatment with oral or intravenous antibiotics was required