RecruitingPhase 1Phase 2NCT06527898

Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer

Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer: a Phase II Trial


Sponsor

Anhui Provincial Hospital

Enrollment

45 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Summary

Concurrent chemoradiotherapy has long been the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. With the introduction of immune checkpoint inhibitors, ADRIATIC study concluded that consolidative Durvalumab after concurrent chemoradiotherapy could achieve a far longer median overall survival of 55.9 months compared with 33.4 months for concurrent chemoradiotherapy. Recently, several studies have demonstrated the safety and efficacy of hypofractionated radiotherapy (3 to 4 Gy) for limited-stage small-cell lung cancer. Hypofractionated radiotherapy processes the advantage of short treatment duration compared with conventional fractionated radiotherapy, which may allow the early participation of immunotherapy. Therefore, we suppose that whether hypofractionated radiotherapy combined with immunotherapy could improve the survival of limited-stage of small-cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a shorter course of high-dose radiation (hypofractionated radiotherapy) with immunotherapy drugs produces better outcomes for patients with limited-stage small-cell lung cancer (a type of lung cancer that has not spread beyond the chest). **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with limited-stage small-cell lung cancer - Your cancer is confirmed to be limited to the chest (via imaging scans) - You are in generally good physical condition (able to carry out daily activities) - Your organs are healthy enough to tolerate treatment **You may NOT be eligible if...** - Your cancer has spread beyond the chest (extensive stage) - You are in poor overall health - Your organs cannot handle chemotherapy, immunotherapy, or radiation - You have not signed an informed consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGhypofractionated radiotherapy with immunotherapy

hypofractionated radiotherapy with Adebrelimab consolidation


Locations(1)

Anhui Provicial Hospital

Hefei, Anhui, China

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NCT06527898