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

Primary Purpose

Solid Tumor

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib and Camrelizumab for Injection
Sponsored by
Beijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing HospitalRecruiting
  • Beijing Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

solid tumor with only liver metastases after first line treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

progression-free survival
From date of registration until the date of disease progresssion or death resulting from any cause.

Secondary Outcome Measures

overall survival
From date of registration until the date of death from any cause or the last follow-up visit.

Full Information

First Posted
April 2, 2021
Last Updated
April 2, 2021
Sponsor
Beijing Hospital
Collaborators
Chinese Society of Clinical Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT04832204
Brief Title
Apatinib Combined With SHR-1210 as Second-line Treatment in Solid Tumors With Only Liver Metastases
Official Title
An Exploratory Study of Apatinib Combined With SHR-1210 as Second-line Treatment in Solid Tumors With Only Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital
Collaborators
Chinese Society of Clinical Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor
Keywords
After first-line treatment failed, only liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
solid tumor with only liver metastases after first line treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apatinib and Camrelizumab for Injection
Other Intervention Name(s)
Apatinib and SHR-1210
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression-free survival
Description
From date of registration until the date of disease progresssion or death resulting from any cause.
Time Frame
Patients will be followed for an average period of 1 year
Secondary Outcome Measure Information:
Title
overall survival
Description
From date of registration until the date of death from any cause or the last follow-up visit.
Time Frame
Patients will be followed for an average period of 1 year
Other Pre-specified Outcome Measures:
Title
1-year survival rate
Description
Percentage of patients alive at 1 year.
Time Frame
12 months
Title
2-year survival rate
Description
Percentage of patients alive at 2 year.
Time Frame
24 months
Title
Safety and tolerability as measured by number and grade of toxicity events
Description
Overall Safety Profile by CTCAE V4.0
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingying Huang
Phone
86-10-85136715
Email
xiaoyudianhh@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingying Huang
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yingying huang
Phone
86 01085136715
Email
xiaoyudianhh@126.com
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingying Huang
Phone
86-10-85136715
Email
xiaoyudianhh@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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