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

Last updated: April 2, 2021
Sponsor: Beijing Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasm Metastasis

Neuroblastoma

Treatment

N/A

Clinical Study ID

NCT04832204
BeijingHY2020-02-07
  • Ages 18-80
  • All Genders

Study 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 Apatinib and SHR-1210 in patients with solid tumors with only liver metastasis (as second-line treatment). The main purpose is to evaluate the disease progression-free survival (PFS) of Apatinib and SHR-1210 in patients with solid tumors with only liver metastasis (progress after first-line treatment). The secondary purpose is to compare the total survival period (OS); 1-year survival rate, 2-year survival rate; evaluation of drug safety; exploration of related biomarkers in specific subgroups to predict effectiveness or adverse reactions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age: ≥18 years old, both male and female;
  2. after pathological diagnosis and first-line treatment failure of advanced solid tumorwith liver metastasis only after consultation by MDT team, the patient had measurablelesions (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 followingstandards: 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 timesnormal upper limit Serum total bilirubin ≤1.5 times normal upper limit, Serumcreatinine ≤1.5 times normal upper limit, Serum albumin ≥30g/L;
  1. expected survival period ≥3 months; 7) women of child-bearing age must undergo apregnancy test (serum or urine) within 7 days prior to enrollment and the result isnegative, and be willing to use appropriate methods of contraception during the trial and 8weeks after the last dose of the test drug.For men, either surgical sterilization orconsent to appropriate methods of contraception during the trial and 8 weeks after the lastadministration of the trial drug; 8) subjects voluntarily joined the study and signed theinformed consent, with good compliance and follow-up.

Exclusion

Exclusion Criteria:

  1. proven allergic to apatinib and/or its excipients;
  2. patients with hypertension and unable to reduce to the normal range afterantihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic bloodpressure >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) andgrade 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;Ahistory of black stool or hematemesis within 2 months;For patients with fecal occultblood (+) and no surgical resection of the primary gastric tumor, gastroscopy isrequired.
  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 orhave 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 thatseriously endanger the safety of patients or affect the completion of the study;
  12. not suitable for inclusion.

Study Design

Total Participants: 20
Study Start date:
March 25, 2021
Estimated Completion Date:
April 30, 2024

Study 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 according to recent studies. It seems there has been clinical evidence to improve the immune microenvironment of the tumor, while in the case of only liver metastasis, the tumor's characteristics may not be consistent with other tumors. This study was to investigate the efficacy and safety of such patients by combining Apatinib and SHR-1210. This study will include approximately 20 patients with solid tumors with only liver metastases (progression after first-line treatment). The investigators will evaluate the efficacy and safety of Apatinib combined with SHR-1210 in these patients. If possible we would check the patients' ctDNA and some infection factors.

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.