esophageal squamous cell carcinoma
Conditions
Interventions
Anlotinib plus immune checkpoint inhibitors (ICIs) Group:N/A
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Histopathologically confirmed unresectable locally advanced, unresectable recurrent or metastatic ESCCs (excluding mixed adeno-squamous carcinoma); 2) Disease progression or intolerance after previous treatment with immune checkpoint inhibitors including PD-1 or PD-L1 or CTLA-4; 3) Patients received Anlotinib combined with immunocheckpoint inhibitors(ICIs) at least one cycle after treatment with front-line ICIs failed (progressed or intolerant); 4) At the beginning of the treatment of Anlotinib combined with ICIs, the PS score of the Eastern Tumor Collaboration group (ECOG) was 0-2; 5) The patient had imaging data within 28 days prior to receiving Anlotinib combined with ICIs, and had at least one measurable lesion according to RECIST 1.1 the efficacy evaluation criteria for solid tumors. At least 1 direction (maximum diameter needed to be recorded) can be accurately measured by magnetic resonance imaging (MRI) or computed tomography (CT), where the longest diameter at baseline is =10 mm (in the case of lymph nodes, short diameter is =15 mm); Measurable lesions should not have received local treatment such as radiotherapy (lesions located within the previous radiotherapy area can also be selected as target lesions if progression is confirmed and RECIST1.1 criteria are met); 6) Male or female patients =18 years of age; 7) Subjects participated in the study voluntarily, good compliance, and able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following will not be included in this study: 1) During the diagnosis of ESCC, the patient was associated with other primary malignant tumors or had a history of other primary malignant tumors, except for the following: a) the malignant tumors that had completely alleviated for at least 2 years before enrollment and did not require any other treatment during the study period; b) Non melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; c) Carcinoma in situ with adequate treatment and no evidence of disease recurrence; 2) The difference between the start date of the ICIs and the Anlotinib is more than 21 days; 3) During the treatment of Anlotinib combined with ICIs, use other systemic anti-tumor drugs other than chemotherapy and/or traditional Chinese medicine that affect the efficacy judgment, but allow radiotherapy for local non target lesions; 4) Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases; 5) Patients with contraindications to restart immunotherapy: a) Grade 2-4 immune myocarditis; b) Severe (3-4 grades) albuminuria; c) Severe or life-threatening (grade 4) immune hepatitis; d) Severe (grade 3-4) immune pneumonia; e) Severe inflammatory arthritis seriously impairing the ability of daily living and quality of life; f) Severe nervous system toxicity: Grade 3-4 myasthenia gravis; Guillain Barre syndrome (GBS) of any grade; Moderate to severe encephalitis (2-4 grades); Transverse encephalitis of any grade; g) Severe (grade 4) pancreatitis; h) Severe or life-threatening (Grade 4) bullous disease; 6) Patients with high risk of bleeding or perforation due to obvious invasion of tumor into adjacent organs of esophageal focus (large artery or trachea), or patients with fistula;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS;Objective Response Rate, ORR;Disease control rate, DCR;Safety; | — |
Countries
China
Contacts
Public ContactHuang Jing
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed