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

Phase 2

Not yet recruiting

• Conditions: Limited Stage Small Cell Lung Cancer
• Interventions: Drug: Probiotics; Radiation: concurrent Hyperfractionated Radiotherapy

• Registration Number: NCT06943235
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-04-30
• Primary Completion: 2027-04-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance	Probiotics	Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.
Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance	concurrent Hyperfractionated Radiotherapy	Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.
Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance	concurrent Hyperfractionated Radiotherapy	Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
One year overall survival rate	one year
one year Survival rate without distant metastasis	one year
Adverse reactions	one year

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China