Rh-Endostatin Combined With CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC
NCT ID: NCT04613284
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
97 participants
INTERVENTIONAL
2020-12-01
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endostar combined Radiation
Recombinant human endostatin (Endostar)
Continuous intravenous infusion of endostar (Simcere Pharma- ceutical, Nanjing, China) was made over 120 h before the begin- ning of radiotherapy, and then repeated every two weeks. The dose was 7.5 mg/m2/24 h 120 h, 14 days/cycle. ECG monitoring was performed during the first delivery of endostar.
Thoracic irradiation of 50 Gy with 3DCRT or IMRT
Concurrent thoracic chemoradiotherapy with reduced irradiation dose of 50 Gy will be given to patients with unresectable stage III NSCLC who can not tolerate irradiation dose to 60 Gy.
Interventions
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Recombinant human endostatin (Endostar)
Continuous intravenous infusion of endostar (Simcere Pharma- ceutical, Nanjing, China) was made over 120 h before the begin- ning of radiotherapy, and then repeated every two weeks. The dose was 7.5 mg/m2/24 h 120 h, 14 days/cycle. ECG monitoring was performed during the first delivery of endostar.
Thoracic irradiation of 50 Gy with 3DCRT or IMRT
Concurrent thoracic chemoradiotherapy with reduced irradiation dose of 50 Gy will be given to patients with unresectable stage III NSCLC who can not tolerate irradiation dose to 60 Gy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1.
* Estimated life expectancy of more than 12 weeks.
Exclusion Criteria
* Active or prior autoimmune disease or history of immunodeficiency.
* Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
* Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
* Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy.
* Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
18 Years
75 Years
ALL
No
Sponsors
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Wuhan University
OTHER
Shanghai Chest Hospital
OTHER
Responsible Party
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Xuwei Cai
Deputy Chief Physician
Other Identifiers
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CXW001
Identifier Type: -
Identifier Source: org_study_id