Clinical Study of PD-1 Monoclonal Antibody SHR-1210 and Apatinib in Advanced NSCLC, Soft Tissue Sarcoma, and Uterine Cancer

Sponsor
Hunan Cancer Hospital
Study ID
NCT04239443
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • PD-1 inhibitor — DRUG
    Intravenous administration of SHR1210 (200mg/2weeks or 200mg/3weeks)
  • Apatinib — DRUG
    NSCLC and Uterine cancer will be given oral of Apatinib (250mg/d), soft tissue sarcoma will be given oral of Apatinib (500mg/d).

Study Details

In this one-arm study, histologically or cytologically confirmed advanced NSCLC, uterine malignancies, and soft tissue sarcoma will be enrolled to investigate the efficacy and safety of PD-1 monoclonal antibody SHR-1210 and apatinib, at the same time, peripheral circulating blood tumor cells (CTC) detection and CTC-based PD-L1 antibody immunofluorescence detection will be performed.

Key Dates

Start date
Jan 30, 2019
Status verified
Jan 2020
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022

Study Design

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

Arms

  • Experimental: SHR1210 and Apatinib
    NSCLC participants will be given intravenous administration of SHR-1210 (200mg/2w) and oral of Apatinib (250mg/d) , soft tissue sarcoma will be given intravenous administration of SHR-1210 (200mg/3w) and oral of Apatinib (500mg/d), and uterine cancer will be given intravenous administration of SHR-1210 (200mg/3w) and oral of Apatinib (250mg/d). The duration of treatment will till the disease progression, death, or unacceptable toxicity show up.

Primary Outcome Measure

Objective remission rate (ORR) [ Time Frame: 2 years ]

Central Contacts

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