Apatinib Combined With SHR-1210 as Second-line Treatment in Solid Tumors With Only Liver Metastases
Solid Tumor
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring After first-line treatment failed, only liver metastases
Eligibility Criteria
Inclusion Criteria:
- age: ≥18 years old, both male and female;
- 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);
- ECOG PS: 0 ~ 1;
- 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:
- proven allergic to apatinib and/or its excipients;
- 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;
- there are multiple factors affecting oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
- 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.
- abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency;
- patients with central nervous system metastasis;
- pregnant or nursing women;
- patients with other malignant tumors within 5 years;
- patients who have a history of psychotropic substance abuse and cannot be cured or have mental disorders;
- patients who have participated in clinical trials of other drugs within 4 weeks;
- 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;
- not suitable for inclusion.
Sites / Locations
- Beijing HospitalRecruiting
- Beijing Hospital
Arms of the Study
Arm 1
Experimental
solid tumor with only liver metastases after first line treatment
Apatinib 250mg, Qd, oral administration,SHR-1210 200mg, q3w one week later, intravenous administration, continuous administration until the disease progresses or an intolerable adverse reaction occurs.