This study is a prospective, exploratory Phase II clinical study aimed at evaluating the safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients with locally advanced or advanced non-small cell lung cancer(NSCLC).
This study is a prospective, exploratory Phase II clinical study aimed at evaluating the safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients with locally advanced or advanced non-small cell lung cancer(NSCLC). Patients with pathologically confirmed unresectable locally advanced/advanced NSCLC with atelectasis were screened and eligible subjects were randomized to receive local intratumoral injection of envolumab/Endostar/recombinant human adenovirus type 5 H101 combined with systemic therapy after signing informed consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Envolimab :150 mg/time, intratumoral injection, at least 5 sites; Recombinant human endostatin: Q3W for 4-6 cycles,Maintenance therapy 210 mg ,CIV 72 hours ,administered as continuous intravenous pump, administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles,intravenous drip.
Recombinant human endostatin: 15mg/time, intratumoral injection, at least 5 sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles,, subcutaneous injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles,intravenous drip.
Recombinant Human Adenovirus Type 5: 1.0ml/time, intratumoral injection, at least 5 sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles,, subcutaneous injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles,intravenous drip.
lung recruitment rate
Imaging studies showed that the lesion dissipated or atelectasis was reduced by 50%
Time frame: every 3 weeks during intratumoral treatment in the first two cycles,At the end of Cycle 1and Cycle2 (each cycle is 281days).
ORR(Objective response rate)
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1
Time frame: Assessed every 6 weeks (within 1 year)or every 9 weeks (1 year later)up to disease progression or death or up to 2 years
DCR(Disease control rate)
DCR was defined as the percentage of CR+PR+SD assessed by the investigator according to RECIST version 1.1
Time frame: Assessed every 6 weeks (within 1 year)or every 9 weeks (1 year later)up to disease progression or death or up to 2 years
PFS(Progression-free survival)
PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first.
Time frame: Assessed every 6 weeks (within 1 year)or every 9 weeks (1 year later)up to disease progression or death or up to 2 years
OS(Overall survival)
OS was defined as the time from first dose to death for any cause
Time frame: up to 2 years
RFS(Recurrence free survival)
RFS was defined as the time from CR to disease progression (PD) or death or up to years, from any cause, whichever occurred first.
Time frame: Assessed every 6 weeks (within 1 year)or every 9 weeks (1 year later)up to disease progression or death or up to 2 years
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EORTC QLQ-C30 scale
The European O-rganization for Reasearch and Treatment of Cancer Quality of Life Questionnare-core 30,There are 30 items in total, of which 29 and 30 items are divided into 7 grades, marked as 1-7 points according to the options, and other items are divided into 4 grades, marked as 1-4 points according to the options.High or low score do not mean a better or worse outcome.
Time frame: up to disease progression or 2 years