GLOBOCAN 2020 reported that the global incidence of esophageal cancer climbed to 604,100, accounting for 3.1% of all tumor sites and ranking 7th out of 36 cancers. In addition, about 544,076 new esophageal cancer deaths, which accounted for 5.5% of all study centers and ranked 6th among 36 cancers. Esophageal squamous cell carcinoma (ESCC) is the most common pathological type of esophageal cancer in China, and accounts for about 90% of cases. Immunotherapy has become the main treatment for second-line and later esophageal cancer patients, but because of the single target, limited mediated signaling pathway, and high drug resistance rate, single-target blocking has limited efficacy. Cadonilimab is a novel humanized bispecific antibody targeted by programmed death receptor 1（PD-1）/cytotoxic T-lymphocyte antigen 4 (CTLA-4)，which can simultaneously block the two immune checkpoint pathways of PD-1 and CTLA-4, indirectly "liberating" immune cells, and improving immune efficacy. Anlotinib inhibits tumor angiogenesis by fully acting on the VEGFR/PDGFR/FGFR pathway, while remodeling tumor microenvironment, increasing T cell activity and infiltration, and synergizing immunotherapy. In addition, the control of local tumors or oligometastases by radiotherapy combined with systemic therapy such as immunotherapy has become an important research direction for metastatic esophageal cancer. This study will explore the efficacy and safety of cadonilimab combined with anlotinib sequential radiotherapy for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) at second or later line.
The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up;
Patients with recurrent/metastatic esophageal squamous cell carcinoma were confirmed by pathology or cytology.
Age≥18 years old, male or female;
Eastern Cooperative Oncology Group（ECOG） score 0-2 points;
Patients with uncontrolled or symptomatic active central nervous system (CNS) metastases (patients with CNS metastases who have been adequately treated, are clinically stable for at least 2 weeks, and have stopped corticosteroids 1 week prior to enrollment can be enrolled, and patients with asymptomatic BMS who do not require treatment can be enrolled);
There is pleural or peritoneal effusion or pericardial effusion that cannot be controlled after effective treatment;
Patients with serious concurrent diseases, such as heart failure, high-risk uncontrolled arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD-stage 4 and above), thyroid insufficiency, mental illness, diabetes, severe chronic diarrhea (more than 7 defecation times per day), etc., and who are deemed unsuitable for participation in this clinical study by the researchers;
The presence of any active, known or suspected autoimmune disease. Admitted subjects who are in a stable state and do not require systemic immunosuppressive therapy;
Single group
Cadonilimab ;Anlotinib
DrugCadonilimab Combined With Anlotinib Followed by Radiotherapy in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Assessment of progression-free survival (PFS) in Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy
PFS is defined as the time from the start of enrollment until tumor progression or death from any cause.
Assessment of objective remission rate (ORR) in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Objective remission rate (ORR): defined as the proportion of subjects whose tumor volume shrinks to a pre-specified value and can be maintained for the minimum time frame required, incorporating cases in complete remission (CR) and partial remission (PR).
Assessment of disease control rate (DCR) in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy
Disease control rate (DCR): the proportion of patients whose tumors shrank or were stable and remained so for a certain period of time, including complete remission (CR), partial remission (PR) and stable disease (SD)
Assessment of overall survival (OS) in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy
OS is defined as the time from the start of enrollment to death from any cause.
Assessment of the incidence of treatment-related adverse evants in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy
Adverse events are observed during the course of the study and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).
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