esophageal cancer
Conditions
Interventions
Single arm:Anlotinib plus Sintilimab
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Man or woman between 18-75 years old and subjects volunteered to join the study and signed informed consent; 2. Histologically and Immunohistochemistry confirmed diagnosis of esophageal squamous cell carcinoma, at least one measurable lesion (by RECIST1.1); 3. Patients who have previously received first-line standard chemotherapy; 4. ECOG PS 0-2; 5. If patients havd received chemoradiotherapy or surgery, it must be more than 4 weeks, and the adverse reactions or wounds have completely recovered. 6. Life expectancy of at least 3 months; 7. Main organs function is normal (1) Blood routine(without blood transfusion within 14 days) a.Hemoglobin (HB) >= 9.0g/dl; b.Absolute value of neutrophil (ANC) >= 1.5 * 10^9 / L; c.Platelet (PLT) >= 80 * 10^9 / L; (2) Liver and Renal function: a. total bilirubin 60ml/min; (3) Thyroid function: T3 1.8-2.9nmol/L, T4 65-155nmol/L, FT3 2.2-6.3pmol/L, FT4 10.3-31.1pmol/L, TSH 0.3-5.0mU/L; 8. The woman patients and female companion of man patients of childbearing age who must agree to take contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors occurred prior to the enrollment; 2. Pregnant or lactating women; 3. Uncontrollable hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg);Patients with Grade II or higher myocardial ischemia, myocardial infarction or malignant arrhythmias (including QTc >= 450 ms); Patients with grade III to IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% (NYHA Classification); 4. Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 5. Gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or suffering from vasculitis,and the history of gastrointestinal hemorrhage within 6 months; 6. Symptomatic central nervous system metastasis; 7. The patient is participating in other clinical studies or completing the previous clinical study in less than 4 weeks; 8. Patients with severe disease that threaten the safety of themselves or affect the completion of the study according to the investigators' judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Object Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;progression-free survival; | — |
Countries
China
Contacts
Public ContactQin Zhang
Jiangsu Cancer Hospital
Outcome results
None listed