About this trial
Comparative analysis of patients with resectable locally advanced esophageal squamous cell carcinoma treated with neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy combined sintilimab versus neoadjuvant chemoradiotherapy.
Eligibility criteria
Qualifiers
Aged 18 to 75, both sexes;
Patients with histologically confirmed locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM stage);
Cervical contrast-enhanced CT showed no suspicious metastatic lymph nodes. Imaging examination showed no systemic metastasis.
R0 resection is expected to be achieved;
Disqualifiers
Malignant tumors other than esophageal cancer (cured localized tumors, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, were not excluded) had occurred within 5 years before randomization; Prostate cancer patients receiving hormone therapy with DFS for more than 5 years were not excluded).
Patients with high blood tendency who had a history of gastrointestinal bleeding within 6 months before randomization, or had coagulopathy at the time of enrollment, or were receiving thrombolysis or anticoagulant therapy;
Previous history of interstitial lung disease or pneumonia requiring steroid treatment at enrollment;
Had active tuberculosis at the time of randomization, or had received anti-tuberculosis therapy within 1 year before randomization;
Trial design
Treatments tested in this trial
- Sintilimab
- radiotherapy
- Chemotherapy
Treatment groups
Sponsors and collaborators
Sichuan Cancer Hospital and Research Institute
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
Anhui Provincial Hospital
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Anyang Tumor Hospital
Collaborator
Shantou Central Hospital
Collaborator
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
GeneCast Biotechnology Co., Ltd.
Collaborator