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

Sponsor
Beijing Hospital
Study ID
NCT04832204
Phase
PHASE2
Status
Unknown

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 25, 2021
Status verified
Apr 2021
Primary completion
Apr 1, 2023
Completion
Apr 30, 2024

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

progression-free survival [ Time Frame: Patients will be followed for an average period of 1 year ]

Central Contacts

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