Sintilimab and Anlotinib Combined With Chemotherapy in Neoadjuvant Treatment of Resectable Esophageal Cancer
Condition: Sintilimab and Anlotinib in Combination With Chemotherapy
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

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-angiogenesis and sintilimab (200 mg) and chemotherapyfor three cycles. Surgical
      treatment was performed 4-6 weeks after the last chemotherapy cycle was completed. The
      primary endpoints assessed were pathological complete response (pCR) rate and safety.
    

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 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 and other necessary
      laboratory tests (such as blood routine, liver and kidney function, electrolytes, and
      cortisol rhythm) to exclude treatment and surgical contraindications and ensure suitability
      for ICIs treatment.

      The exclusion criteria were as follows: Patients unable to tolerate surgery, those with
      refractory hypertension and proteinuria, those who had previously received other treatments,
      and 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).

      Treatment regimen:

      Patients were administered preoperatively with sintilimab (200 mg, Day 1) and anlotinib (10
      mg, orally, once daily, 2 weeks on and 1 week off) in combination with chemotherapy (albumin
      paclitaxel 130 mg/m2, Days 1 and 8 + nedaplatin 80 mg/m2, Day 1) for three cycles of
      neoadjuvant therapy. Surgical intervention (either Mckeown or Ivor Lewis approach) was
      performed 4-6 weeks after completing the last treatment cycle of neoadjuvant therapy. After
      the 4th week after surgery, patients received maintenance therapy with sintilimab (200 mg,
      Q3W) for 1 year. If any adverse reactions of grade 3 or higher occurred during the treatment,
      the dose of chemotherapeutic drugs was reduced by 25% until the patient's condition recovered
      to grade 1 or returned to normal, and the subsequent treatment cycle was continued. In case
      of grade 3 or higher hypertension or proteinuria, the dose of anlotinib was reduced to 8 mg.
      It was discontinued if the condition could not recover to grade 1-2 after symptomatic
      treatment.
    

Intervention name(s): Sintilimab and anlotinib in combination with chemotherapy
Intervention type(s): Drug
Intervention description(s): Neoadjuvant treatment involved administering anlotinib (10 mg orally, once a day, 2 weeks on and 1 week off) for anti-angiogenesis and sintilimab (200 mg) and chemotherapyfor three cycles. Surgical treatment was performed 4-6 weeks after the last chemotherapy cycle was completed. The primary endpoints assessed were pathological complete response (pCR) rate and safety.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal cancer; neoadjuvant; efficiency