Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Camrelizumab + apatinib
Sponsors
Bozhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Subjects with esophageal squamous cell carcinoma diagnosed by histopathology or cytology (IIB-IIIB); 3. Patients with esophageal cancer who have not progressed after concurrent chemoradiotherapy; 4. ECOG PS score 0-1 points; 5. Expected survival period >= 3 months; 6. The main organ functions are normal, and there are no patients with severe blood, heart, lung, liver, kidney, bone marrow. Laboratory tests meet the following requirements: (1) Hemoglobin (Hb) >= 90 g/L; (2) White blood cells (WBC) >=3.0x10^9/L; neutrophil count (NEUT) >=1.5x10^9/L; (3) Platelet (PLT)>=100x10^9/L (4) Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level <= 2.5 times the upper limit of normal (ULN); renal function (serum creatinine sCr) level <= 1.5 times the upper limit of normal (ULN); (5) Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); (6) Urine protein and urine occult blood <2+; fecal occult blood <2+; 7. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 8. The investigator believes that the treatment can be beneficial.
Exclusion criteria
Exclusion criteria: 1. Those who have been confirmed to be allergic to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy; 3. Suffer from any active autoimmune disease or history of autoimmune disease; 4. People with congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/mL), hepatitis C (hepatitis C antibody positive, and high HCV-RNA) (Under the detection limit of the analytical method) or co-infection with hepatitis B and C; or a history of organ transplantation; 5. Cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; 6. Pregnant or lactating women; 7. According to the judgment of the investigator, patients who are not suitable for inclusion in this study; 8. Those who have medical systemic diseases and psychiatric diseases that are not suitable for chemotherapy; 9. Those who have acute infection and need antibiotic treatment; 10. Patients who have participated in other drug clinical trials within four weeks; 11. Patients who may be accompanied by high-risk diseases such as esophageal cancer perforation and bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;2-year survival rate; | — |
Countries
China
Contacts
Public ContactShi Zhenshan
Bozhou People's Hospital
Outcome results
None listed