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This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.
This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.
Patients with locally advanced stage III squamous non-small cell lung cancer who have not received systematic treatment in the past and cannot be treated surgically, after signing informed consent, qualified subjects who meet the inclusion criteria will be screened. They will receive 2 cycles of recombinant human endostatin combined with envafolimab and platinum containing chemotherapy. Radiotherapy will be carried out simultaneously in cycles 1-2, and after 2 cycles, they will receive maintenance treatment with envafolimab until the disease progresses and intolerable toxicity is detected, The treatment period does not exceed 12 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recombinant human endostatin Group | Experimental | Recombinant human endostatin and enrolizumab injection combined with Synchronal Radiochemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Endostatin Injection | Drug | Recombinant Human Endostatin Injection:210 mg, intravenous infusion for 72 hours, once every three weeks cycle Evafolimab Injection:Subcutaneous injection on day 1, 8, and 15, once every three weeks cycle |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | After treatment, the ratio of patients assessed as CR and PR according to RECIST 1.1 | After 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from the start of treatment to death or last follow-up | The time from the start of treatment to death or last follow-up |
| Progression-free survival | The time from the start of treatment to the first recording of disease progression. |
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Inclusion Criteria:
Exclusion Criteria:
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Share mid-term data results and final data analysis results
Half a year to one year after the start of the research
All can be accessed
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| ID | Term |
|---|---|
| D043169 | Endostatins |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| The time from the start of treatment to the first recording of disease progression |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |