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

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ClinicalTrials.gov Identifier: NCT04832204
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
Chinese Society of Clinical Oncology
Information provided by (Responsible Party):
Yingying Huang, Beijing Hospital

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 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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Apatinib and Camrelizumab for Injection Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study of Apatinib Combined With SHR-1210 as Second-line Treatment in Solid Tumors With Only Liver Metastases
Estimated Study Start Date : March 25, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 2024

Arm Intervention/treatment
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.
Drug: Apatinib and Camrelizumab for Injection
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.
Other Name: Apatinib and SHR-1210




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: Patients will be followed for an average period of 1 year ]
    From date of registration until the date of disease progresssion or death resulting from any cause.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: Patients will be followed for an average period of 1 year ]
    From date of registration until the date of death from any cause or the last follow-up visit.


Other Outcome Measures:
  1. 1-year survival rate [ Time Frame: 12 months ]
    Percentage of patients alive at 1 year.

  2. 2-year survival rate [ Time Frame: 24 months ]
    Percentage of patients alive at 2 year.

  3. Safety and tolerability as measured by number and grade of toxicity events [ Time Frame: 12 months ]
    Overall Safety Profile by CTCAE V4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832204


Contacts
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Contact: Yingying Huang 86-10-85136715 xiaoyudianhh@126.com

Locations
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China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: yingying huang    86 01085136715    xiaoyudianhh@126.com   
Beijing Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Contact: Yingying Huang    86-10-85136715    xiaoyudianhh@126.com   
Sponsors and Collaborators
Beijing Hospital
Chinese Society of Clinical Oncology
Investigators
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Principal Investigator: Yingying Huang Beijing Hospital
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Responsible Party: Yingying Huang, Associate Chief Physician, Beijing Hospital
ClinicalTrials.gov Identifier: NCT04832204    
Other Study ID Numbers: BeijingHY2020-02-07
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yingying Huang, Beijing Hospital:
After first-line treatment failed
only liver metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action