A Phase 4 interventional study of Recombinant human endostatin (Endostar) and Thoracic irradiation of 50 Gy with 3DCRT or IMRT in Lung Cancer, sponsored by Shanghai Chest Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Shanghai Chest Hospital · Phase 4, Interventional, and Treatment
A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation.
A Phase II, Single-arm, Multi-centre Study of Durvalumab as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) Therapy (Relief)
Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Recombinant human endostatin (Endostar) · Radiation: Thoracic irradiation of 50 Gy with 3DCRT or IMRT
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.
Also known as: Durvalumab
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.
Progression Free Survival
PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
Time frame: up to approximately 3 years
adverse events (AE)
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: 5 years from patient enrollment
Overall Survival
OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.
Time frame: up to 5 years from patient enrollment
Objective Response Rate
ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
Time frame: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter up to 3 three years
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Shanghai Chest Hospital