The goal of this clinical trial is to learn if cadonilimab combined with anlotinib can be a safe and effective neoadjuvant therapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). The main questions it aims to answer are:
What level of pathological complete response (pCR) rate can be achieved with this neoadjuvant regimen? Is this neoadjuvant regimen safe enough with acceptable toxicity?
Participants will:
Receive cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles.
Undertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication.
Accept an follow-up for 2 years after surgery.
Able to provide written informed consent and understand and agree to comply with the requirements of this study as well as the assessment schedule.
Be at least 18 years of age on the date of signing the ICF.
Histopathologically confirmed esophageal squamous cell carcinoma: the clinical stage is T1-2N1-3M0, T2 (diameter≥3 cm) N0M0 or T3-4aN0-3M0 (stage II-IVA), and the staging should be based on the AJCC 8th edition esophageal cancer staging system.
Patients are asked to provide an archival tumor tissue sample (FFPE tissue block or approximately 15 [≥6] freshly cut unstained FFPE sections) and a pathology report of this baseline sample. If no archival sample is available or the sample is not available, a biopsy sample is requested at baseline.
Previous treatment for current esophageal cancer, including chemotherapy or radiotherapy.
Prior receipt of antibodies or drugs targeting immune checkpoint pathways, including but not limited to anti-cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4), anti-PD-1, and anti-PD-L1 therapeutic antibodies.
Patients with non-squamous cell carcinoma.
Presence of locally advanced, unresectable disease, regardless of disease stage and presence or absence of metastases (stage IV).
Peking University People's Hospital
Lead sponsor
Akeso Pharmaceuticals, Inc.
Collaborator