Camrelizumab Combined With Endostar for First-line Treatment in Subjects With Advanced Squamous NSCLC

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT04303130
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Carelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes (the overall infusion time including the flushing time is not shorter than 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance. The combination regimen is a medication cycle every three weeks (21 days).

Study Details

This study is a single-arm, prospective, multi-center clinical trial. designed to evaluate patients with stage IV inability to receive or refuse chemotherapy.Efficacy and safety of first-line treatment with Camrelizumab and Endo in advanced lung squamous cell carcinoma

Key Dates

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

Study Design

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

Arms

  • Experimental: Camrelizumab (SHR-1210) Combined With Endostar
    Carelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance. The combination regimen is a medication cycle every three weeks (21 days).

Primary Outcome Measure

PFS (Progression-Free survival) [ Time Frame: 1 Year ]

Central Contacts

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