Status:
UNKNOWN
Apatinib Combined With SHR-1210 as Second-line Treatment in Solid Tumors With Only Liver Metastases
Lead Sponsor:
Beijing Hospital
Collaborating Sponsors:
Chinese Society of Clinical Oncology
Conditions:
Solid Tumor
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Apatinib and SHR-1210 are new drugs produced by jiangsu hengrui pharmaceutical co., LTD. Both are listed in China. The investigators want to design a trial to explore the efficacy and safety of Apatin...
Detailed Description
Any solid tumor in the presence of liver metastasis indicates poor prognosis, short overall survival, immunotherapy combination with anti-tumor angiogenesis agents have some curative effection accordi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04832204
Start Date
March 25 2021
End Date
April 1 2024
Last Update
April 5 2021
Active Locations (2)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100005
2
Beijing Hospital
Beijing, Beijing Municipality, China, 100730