Status:
COMPLETED
Sintilimab and Anlotinib Combined With Chemotherapy in Neoadjuvant Treatment of Resectable Esophageal Cancer
Lead Sponsor:
Tang-Du Hospital
Conditions:
Sintilimab and Anlotinib in Combination With Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study focused on patients with T2-4NxM0 resectable esophageal carcinoma. Neoadjuvant treatment involved administering anlotinib (10 mg orally, once a day, 2 weeks on and 1 week off) for anti-angio...
Detailed Description
The study was conducted from April 2021 to April 2022 at our hospital and was approved by the Ethics Committee of Tangdu Hospital. The inclusion criteria were as follows: patients aged 18-75 years wit...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- patients aged 18-75 years with a histopathologic diagnosis of esophageal cancer staged according to the AJCC eighth edition as T1-4N1-3M0. If patients were staged as T2N0M0, the esophageal lesions had to be ≥5 cm.
- Before enrollment, all patients underwent various examinations, including cardiac color ultrasound (left ventricular ejection fraction of at least 50%), pulmonary function (forced expiratory volume-1 \[FEV1\] ≥1.5 L), enhanced chest computed tomography (CT), abdominal color ultrasound, cervical lymph node color ultrasound ▪ other necessary laboratory tests (such as blood routine, liver and kidney function, electrolytes, and cortisol rhythm) to exclude treatment and surgical ontraindications and ensure suitability for ICIs treatment.
- Exclusion Criteria:
- Patients unable to tolerate surgery
- those with refractory hypertension and proteinuria
- those who had previously received other treatments
- those who were not suitable candidates for ICIs (due to conditions such as hepatitis B with viral quantification \>2000 IU, systemic lupus erythematosus, and xerosis).
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06015035
Start Date
April 1 2021
End Date
April 1 2022
Last Update
August 29 2023
Active Locations (2)
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1
Hongtao Duan
Xi’an, Shanxi, China, 710038
2
Tangdu Hospital, the Air Force Military University
Xi'an, China, 710038