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

NCT04832204 | Unknown Phase 2 DMC

• 1 other identifier: BeijingHY2020-02-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor

Keywords

After first-line treatment failed; only liver metastases

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  From date of registration until the date of disease progresssion or death resulting from any cause.

  Patients will be followed for an average period of 1 year

Secondary Outcomes (1)

• overall survival

  Patients will be followed for an average period of 1 year

Other Outcomes (3)

• 1-year survival rate

  12 months

• 2-year survival rate

  24 months

• Safety and tolerability as measured by number and grade of toxicity events

  12 months

Study Arms (1)

solid tumor with only liver metastases after first line treatment

EXPERIMENTAL

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

Interventions

Apatinib and Camrelizumab for Injection DRUG

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.

Also known as: Apatinib and SHR-1210

solid tumor with only liver metastases after first line treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \) 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Hospital: lead
• Chinese Society of Clinical Oncology: collaborator

Study Sites (2)

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

MeSH Terms

Interventions

apatinib; camrelizumab; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yingying Huang

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingying Huang

CONTACT

86-10-85136715; xiaoyudianhh@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: March 25, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

CN (2)