oesophageal squamous cell carcinoma
Conditions
Interventions
experimental group:Drug: Tislelizumab + Renvastinib mesylate capsules + irinotikan liposomes
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient had good compliance, could understand the research process of the study, and signed a written informed consent; 2. Age 18-75 years old, male or female; 3. Histologically or cytologically proven unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma; 4. Failure of first-line standard treatment (first-line standard treatment should include immunotherapy); 5. At least one measurable lesion as assessed according to RECIST 1.1 criteria; 6.ECOG 0-2; 7. The expected survival time is greater than 3 months; 8. Appropriate organ function, defined as follows: (Patients who have completed hematology and blood biochemistry tests within 14 days prior to enrollment, have not received blood transfusion, albumin, recombinant human thrombopoietin or colony-stimulating factor treatment, and meet the following criteria) a. Absolute neutrophil count (ANC) =1.5×109/L b. Hemoglobin =90g/dL c. Platelets (PLT) =100×109/L d. Total bilirubin < Upper limit of normal (ULN) e. Chemical examination of Liver function index (AST&ALT) <2.5 times the upper limit of normal value (ULN) (AST and ALT in patients with liver metastasis =5×ULN) f. Serum creatinine =1.2mg/dL and creatinine clearance =50mL/min (urine collected for 24 hours or calculated using the Cockroft-Gault method) 9. If female subjects have negative HCG in their blood or urine (except those who have undergone menopause and hysterectomy), women and men of childbearing age agree to use effective contraception when engaging in sexual activity. Consent to use effective contraception during treatment and for at least 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.the presence of other known malignancies in the last 5 years prior to study treatment, other than treated basal cell and squamous cell carcinoma of the skin and/or treated cervical and/or breast cancer in situ; 2. Known central nervous system metastases; 3. Active infection: If HIV infection and chronic HBV/HCV are in the active stage (if HBV DNA=104 copy number or =2000IU/mL, antiviral liver protection treatment is required first, HBV DNA < 104 copy number or < 2000IU/mL can be enrolled, and continue to take antiviral drugs, monitor liver function and HBV viral load); 4. There are serious concomitant diseases, such as diabetes and can not be well controlled by hypoglycemic drugs, clinically serious (that is, active) heart disease, renal failure, liver failure, uncontrolled epilepsy, central nervous system disease or history of mental disorders, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, etc.; 5. Received any anti-tumor therapy such as radiotherapy or chemotherapy within 4 weeks before the first dose; Or received Chinese medicine with anti-tumor indications within 2 weeks before the first administration; Or received small molecule targeted drug therapy within 4 weeks or 5 half-lives before the first administration of the drug (if the extraction time is short); 6. Known allergy to components related to irinotecan liposomes and Renvastinib mesylate capsules; 7. Participated in other clinical investigators within 4 weeks before enrollment; 8. Patients deemed unsuitable for this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Disease control rate;Clinical benefit rate;Overall Survival;safety; | — |
Countries
China
Contacts
Public ContactYifu He
Anhui Provincial Cancer Hospital
Outcome results
None listed