PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
Eligibility criteria
Qualifiers
Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
Patients must not have received any prior anticancer therapy.
More than 6 months of expected survival.
Age ranges from 18 to 70 years.
Disqualifiers
Patients have received any prior anticancer therapy.
Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
Patients with concomitant hemorrhagic disease.
Patients who cannot tolerate surgery.
Trial design
Treatments tested in this trial
- Sintilimab
- Preoperative radiotherapy
- Paclitaxel
- Cisplatin
- esophagectomy
Treatment groups
422 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Affiliated Cancer Hospital of Shantou University Medical College
Collaborator
Source ClinicalTrials.gov