Trials / Unknown
UnknownNCT04613284
Rh-Endostatin Combined With CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC
Rh-Endostatin Combined With Low-dose CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC Who Can Not Tolerate 60 Gy Irradiation
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 97 (estimated)
- Sponsor
- Shanghai Chest Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| RADIATION | 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. |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2022-02-01
- Completion
- 2023-08-01
- First posted
- 2020-11-03
- Last updated
- 2020-11-03
Source: ClinicalTrials.gov record NCT04613284. Inclusion in this directory is not an endorsement.