Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
NCT Number: NCT04951063
This Phase 1 trial aimed to determine the maximum tolerated fraction dose (MTD) of hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced non-small cell lung cancer (LA-NSCLC).
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Guangzhou, Guangdong, 510000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exit criteria
Split-course adaptive HRT-CHT is administered at the following three dose levels:
weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT
Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.
Time frame: 1 year
The maximum tolerated fraction dose was defined as the highest DL in which <=2 patients of the 6 treated patients experienced G3+ toxicity and <=1 patient experienced G4+ toxicity within 12 months after RT. If a patient had multiple types of toxicities, only the highest grade of toxicity was counted.
Time frame: 2 months after radiotherapy
Proportion of patients with PR and CR at 2 months after radiotherapy
Time frame: 1-year
Time frame: 1-year
Time frame: 1-year
Time frame: 1-year
Sun Yat-sen University
Other
Fraction Dose Escalation of Hypofractionated Radiotherapy With Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: a Phase 1 Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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