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Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma

RecruitingPhase 1Ages 18 Years - 70 YearsAllAffiliated Cancer Hospital of Shantou University โ€ฆ
NCT05984342 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Esophageal cancer is one of the most common malignancies in China, and esophageal squamous cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a standard therapeutic approach for patients with resectable ESCC, but the prognosis is still disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced ESCC, it is still an infrequently used procedure in China. The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577 trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed a prospective randomized controlled tial to study whether immunotherapy

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged between 18 and 70 years 2. Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy) 3. Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes ๏ผˆT1-3N1-3M0๏ผ‰ 4. undergoing radical esophagectomy 5. ECOG (Eastern Cooperative Oncology Group) : 0-1 6. No recurrent disease before adjuvant therapy 7. Normal hemodynamic indices before the recruitment 8. Able to understand this study and have signed informed consent Exclusion Criteria: 1. previous or concurrent malignancy 2. Interstitial lung disease 3. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications 4. Known or suspected allergy to chemotherapeutic drugs or Tislelizumab 5. Active autoimmune disease 6. Active hepatitis 7. Those whom the investigator considered unsuitable for inclusion
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What it tests

  • Tislelizumab
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Where

1 site
Cancer Hospital of Shantou University Medical College
Shantou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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