esophageal squamous cell carcinoma
Conditions
Interventions
Potentially resectable group:Patients enrolled in the study will undergo a relevant medical history collection and receive at least two cycles of treatment with tislelizumab (200 mg IV D1 Q3W) in comb
Surgical contraindication group:Patients enrolled in the study will undergo a collection of relevant medical histories and receive at least two cycles of treatment with tislelizumab (200 mg IV D1 Q3W)
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Inclusion Criteria: Age range: 18-80 years old; Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor; Patients with potentially resectable esophageal cancer confirmed by imaging and endoscopic examinations (T1b-3, N0, M0, with a tumor size not exceeding 5 cm and occupying less than 2/3 of the luminal circumference); Patients who have not received any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy; Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III; Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period; Patients who have signed the informed consent form. 2: Inclusion Criteria: Individuals aged above 18 years; Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor; Patients with esophageal cancer deemed as surgically contraindicated (including those with cervical esophageal cancer, surgical contraindications, those who refuse surgery, or those considered high-risk for esophagectomy, defined as having at least one of the following characteristics: (1) age over 75 years, (2) Charlson comorbidity index >= 2, (3) presence of moderate lung dysfunction, (4) malnutrition (with a body mass index below 18 kg/m^2)), with a clinical staging of cT1b-3N0M0, a tumor size not exceeding 5 cm, and occupying less than 2/3 of the luminal circumference; Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy; Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period; Patients who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Exclusion Criteria: Patients with potential tracheoesophageal fistula or aortoesophageal fistula; Patients with severe malnutrition or requiring tube feeding; Patients with other malignancies that have not been cured within the past 2 years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix); Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy; Immunocompromised patients, or patients who are still receiving systemic steroids (prednisone > 10 mg/day or equivalent) or other forms of immunosuppressive therapy within 7 days before the first dose of neoadjuvant therapy in this study; Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study; Patients with a history of allogeneic organ or stem cell transplantation; Patients with allergies to drugs or related components involved in this study; Patients who are currently participating in any other clinical study. 2: Exclusion Criteria: Patients with allergies to the drugs or related components involved in this study; Patients who are currently participating in any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Organ preservation rate;Safety;Two-year overall survival rate; | — |
Countries
China
Contacts
Public ContactZhou Pinghong, Tan Lijie
Zhongshan hospital, Fudan University
Outcome results
None listed