Esophageal Squamous Cell Cancer
Conditions
Interventions
Cohort 1 (metastatic ESCC) : anlotinib + radiotherapy ± chemotherapy:None
Cohort 2 (locally advanced ESCC) observational group: anlotinib + radiotherapy ± chemotherapy:None
Cohort 2 (locally advanced ESCC) control group: radiotherapy ± chemotherapy:None
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC, excluding mixed adenocarcinoma) is required. 2. During the study observation period, patients completed radiotherapy according to the treatment plan. In Cohort 1 and the observational group of Cohort 2, patients received at least one cycle of anlotinib alongside radiotherapy or chemoradiotherapy. Anlotinib was administered during the same treatment phase, either in combination with radiotherapy, as sequential therapy, or as maintenance therapy. In Cohort 2’s control group, patients received only radiotherapy or chemoradiotherapy without anlotinib. Patients in both Cohorts 1 and 2 could undergo either concurrent or sequential chemoradiotherapy. 3. Radiotherapy targeted the primary lesion or metastatic sites (e.g., liver, lung, lymph nodes) of esophageal cancer, and may also include treatment for brain or bone metastases; however, patients receiving radiotherapy solely for bone or brain metastases were excluded from this study. 4. The radiotherapy dose was 1.8-2.2 Gy per fraction, with a total dose of =45 Gy; or stereotactic body radiotherapy (SBRT) of =3 Gy per fraction, with a total dose of =30 Gy. 5. At the start of radiotherapy, patients had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2. 6. Patients underwent at least one imaging assessment within 28 days prior to starting radiotherapy or anlotinib treatment for baseline evaluation. After anlotinib combined with radiotherapy, at least one imaging assessment was required for efficacy evaluation. Efficacy assessments were based on the RECIST version 1.1 criteria, where local treatments such as radiotherapy, ablation, or particle therapy could be considered "non-target lesions" if confirmed to have progressed and meeting RECIST 1.1 criteria. 7. Patients must be male or female aged =18 years.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with esophageal squamous cell carcinoma (ESCC) who have a history of other primary malignancies or are currently diagnosed with another primary malignancy are excluded, with the following exceptions: a) malignancies that have been in complete remission for at least two years prior to enrollment and require no further treatment during the study; b) non-melanoma skin cancer or malignant melanoma that has been adequately treated and shows no evidence of disease recurrence; c) carcinoma in situ that has been adequately treated and shows no evidence of disease recurrence. 2. Patients receiving other targeted therapies that may affect efficacy assessment (e.g., apatinib or other anti-angiogenic agents, or cetuximab and other EGFR-targeted therapies) during the study period are excluded, although immunotherapy (such as PD-1/PD-L1/CTLA-4 inhibitors) is permitted. 3. Patients whose radiotherapy end date and anlotinib start date differ by more than six weeks, or whose anlotinib end date and radiotherapy start date differ by more than six weeks, are excluded. 4. Patients with tumors that significantly invade adjacent organs (such as major arteries or the trachea) causing a high risk of bleeding or perforation, or who have developed a fistula, are excluded prior to the use of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Progression Free Survival;Safety; | — |
Countries
China
Contacts
Public ContactXin Wang
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed