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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06943235

Enrollment

Registered

2025-04-24

Start date

2025-04-25

Completion date

2027-12-30

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limited Stage Small Cell Lung Cancer

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Sign written informed consent before implementing any experimental procedures; 2. Age range: 18-80 years old; 3. Pathological diagnosis of small cell lung cancer; 4. Limited stage; 5. ECOG PS 0-1； 6. Receive ≤ 2 rounds of chemotherapy or chemotherapy plus immunotherapy; 7. Expected survival time\>3 months;

Exclusion criteria

1. Progress after 2 induction treatments; 2. Severe emphysema, interstitial changes in the lungs, COPD patients; 3. Resting blood oxygen\<93; 4. Have a history of other malignant tumors and have received chemotherapy in the past 3 years; 5. History of chest radiotherapy;

Design outcomes

Primary

Measure	Time frame
one year progression free survival rate	one year
Complete response rate at the end of radiotherapy for one month	at the end of radiotherapy for one month

Secondary

Measure	Time frame
One year overall survival rate	one year
one year Survival rate without distant metastasis	one year
Adverse reactions	one year

Countries

China

Contacts

CONTACTXingwen Fan

wenxingfan@126.com+86 13651669687

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026