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).
Single group
Cadonilimab plus anlotinib
Drugcadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles
Pathological Complete Response (pCR) Rate
Pathological complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in primary tumor site or lymph nodes as evaluated by blinded independent pathological review (BIPR).
Major Pathological Response (MPR) Rate
Major pathological response (MPR) rate is defined as the percentage of participants with less than or equal to 10% of residual viable tumor in primary tumor site or lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the Percentage of participants achieving complete response (CR) or partial response (PR) in all patients with measurable disease at baseline, as assessed by the investigator according to RECIST version 1.1.
Treatment Emergent Adverse Events (TEAE)
The incidence and severity of treatment emergent adverse events (including adverse events, serious adverse events and immune-related adverse events) among all participants.
Event-free Survival (EFS)
EFS is defined as the time from participation to any of the following events: progression of disease, recurrence disease, or death due to any cause. Progression/recurrence will be assessed either by biopsy assessed by local pathologist or by investigator-assessed imaging using RECIST version 1.1.
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Peking University People's Hospital
Lead sponsor
Akeso Pharmaceuticals, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
