Sintilimab Plus NCT or NCRT Versus NCRT for ESCC

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Cancer Hospital and Research Institute

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

420 Participants
are divided into 3 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