An Exploratory Study of Apatinib Combined With SHR-1210 as Second-line Treatment in Solid Tumors With Only Liver Metastases

Fecha de inicio: 25 de marzo de 2021

Inclusion Criteria: 1. age: ≥18 years old, both male and female; 2. after pathological diagnosis and first-line treatment failure of advanced solid tumor with liver metastasis only after consultation by MDT team, the patient had measurable lesions (helical CT scan ≥10mm, meeting the RECIST 1.1 standard); 3. ECOG PS: 0 \~ 1; 4. subjects' baseline blood routine and biochemical indicators shall meet the following standards: Hemoglobin ≥80g/L, Absolute neutrophils count (ANC) ≥1.5×109/L, Platelet ≥90×109/L, ALT and AST≤2.5 times normal upper limit, and liver metastasis ≤5 times normal upper limit Serum total bilirubin ≤1.5 times normal upper limit, Serum creatinine ≤1.5 times normal upper limit, Serum albumin ≥30g/L; 6\) expected survival period ≥3 months; 7) women of child-bearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the result is negative, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last dose of the test drug.For men, either surgical sterilization or consent to appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; 8) subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up. Exclusion Criteria: 1. proven allergic to apatinib and/or its excipients; 2. patients with hypertension and unable to reduce to the normal range after antihypertensive drug treatment (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg), coronary heart disease at or above grade I, grade I arrhythmia (including QTc interphase prolonging \> 450 ms in males and \> 470 ms in females) and grade I cardiac dysfunction;Patients with positive urinary protein; 3. there are multiple factors affecting oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. patients with a clear tendency of gastrointestinal bleeding, including the following: local active ulcer lesions, and fecal occult blood (++) is not included in the group;A history of black stool or hematemesis within 2 months;For patients with fecal occult blood (+) and no surgical resection of the primary gastric tumor, gastroscopy is required. 5. abnormal coagulation function (INR\>1.5, APTT\>1.5 ULN), with bleeding tendency; 6. patients with central nervous system metastasis; 7. pregnant or nursing women; 8. patients with other malignant tumors within 5 years; 9. patients who have a history of psychotropic substance abuse and cannot be cured or have mental disorders; 10. patients who have participated in clinical trials of other drugs within 4 weeks; 11. according to the judgment of the researcher, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 12. not suitable for inclusion.