esophageal cancer
Conditions
Interventions
Intervention group:AK105 combined with anlotinib
Sponsors
General Hospital of Pingmei Shenma Medical Group
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75 years old, male or female; 2.Esophageal squamous cell carcinoma or adenosquamous cell carcinoma (mainly squamous cell differentiation) confirmed by histology; 3.Unresectable advanced recurrent or metastatic esophageal cancer; 4.Subjects must not be suitable for radical treatment, such as radical chemoradiotherapy and/or surgery; 5.Did not receive systemic treatment before; 6.KPS score >= 70; 7.There were measurable lesions in accordance with iRECIST standard; 8.The expected survival time is more than 3 months; 9.The function of main organs was normal, and there was no serious abnormal blood, heart, lung, liver and kidney function and immunodeficiency disease.
Exclusion criteria
Exclusion criteria: 1.Patients who have previously used chemotherapy drugs / targeted drugs / immunotherapy; 2.Known allergy to arotinib hydrochloride, AK-105 or any component; 3.Patients with brain metastasis or meningeal metastasis symptoms or need treatment; 4.Imaging (CT or MRI) showed that the tumor obviously invaded the adjacent organs of esophageal lesions (large artery or trachea), resulting in patients with high risk of bleeding and fistula; 5.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 500 IU / mL), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of analytical method) or co infection of hepatitis B and hepatitis C; 6.Immunosuppressive drugs were used in the past 14 days before the first use of ak-105, excluding nasal and inhaled corticosteroids or physiological dose of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose of drugs); 7.Vaccinate live attenuated vaccine within 4 weeks before the first administration or planned during the study period; 8.Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure 450 ms in male and > 470 MS in female) and cardiac insufficiency of >= 2 grade; 10.There are many factors affecting oral drug absorption, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 11.Routine urine examination showed that urine protein was >= (++), or 24-hour urine protein was more than or equal to 1.0g; 12.Abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN) and bleeding tendency;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;Objective remission rate;Overall survival;Progression free survival;Living quality; | — |
Countries
China
Contacts
Public ContactLiu Jiarong
General Hospital of Pingmei Shenma Medical Group
Outcome results
None listed