RecruitingPhase 2NCT06943235

Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)

A Prospective, Multicenter, Randomized Controlled, Phase II Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)


Sponsor

Fudan University

Enrollment

60 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

ADRIATIC study explored the benefits of immune maintenance therapy after LS-SCLC radiotherapy and chemotherapy. In the presence of immunotherapy, is it necessary to increase the dosage of radiotherapy and can it further improve the efficacy? This study aims to explore the efficacy and safety of simultaneous integrated boost hyperfractionation radiotherapy combined with probiotics and Adalberg monoclonal antibody consolidation therapy for small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding probiotics (beneficial gut bacteria supplements) to the standard treatment — combined chemotherapy and radiation — plus maintenance immunotherapy with adebrelimab, improves outcomes for patients with limited-stage small cell lung cancer. **You may be eligible if...** - You are aged 18–80 - You have been confirmed to have small cell lung cancer, limited stage (confined to one side of the chest) - Your performance status is good (ECOG 0–1) - You have received no more than 2 rounds of prior chemotherapy or chemo-immunotherapy - Your expected survival is more than 3 months **You may NOT be eligible if...** - Your cancer progressed after 2 rounds of initial treatment - You have severe emphysema, significant COPD, or lung interstitial changes - Your resting blood oxygen is below 93% - You have had another cancer requiring chemotherapy in the past 3 years - You have previously received chest radiation 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

DRUGProbiotics

Subjects received probiotics before radiotherapy

RADIATIONconcurrent Hyperfractionated Radiotherapy

Increase radiation dose on the basis of conventional radiotherapy

DRUGImmunotherapy

Adebrelimab, 1200mg,q3w,2 year


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06943235


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