Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tislelizumab.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 could be used with chemotherapy after surgery to improve overall survival in these patients. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.
Interventions
- Drug Tislelizumab
Adjuvant Chemotherapy （nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2 d1-3) in combination with Tislelizumab (200 mg Q3W)
Primary outcome measures
- disease-free survival rate [Time frame: 1 years after surgery]
Secondary outcome measures (1)
- Rate of adverse events [Time frame: within 6 months]
Eligibility criteria
Inclusion criteria
- Aged between 18 and 70 years
- Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0）
- undergoing radical esophagectomy
- ECOG (Eastern Cooperative Oncology Group) : 0-1
- No recurrent disease before adjuvant therapy
- Normal hemodynamic indices before the recruitment
- Able to understand this study and have signed informed consent
Exclusion criteria
- previous or concurrent malignancy
- Interstitial lung disease
- Requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- Known or suspected allergy to chemotherapeutic drugs or Tislelizumab
- Active autoimmune disease
- Active hepatitis
- Those whom the investigator considered unsuitable for inclusion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital of Shantou University Medical College — Shantou
Identifiers
NCT: NCT05984342 · 2023045