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

NCT06943235 | Recruiting Phase 2

• 1 other identifier: 2503317-7
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Limited Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• One year overall survival rate

  one year

• one year Survival rate without distant metastasis

  one year

• Adverse reactions

  one year

Study Arms (2)

Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance

EXPERIMENTAL

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.

Drug: Probiotics; Radiation: concurrent Hyperfractionated Radiotherapy; Drug: Immunotherapy

Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance

PLACEBO COMPARATOR

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.

Radiation: concurrent Hyperfractionated Radiotherapy; Drug: Immunotherapy

Interventions

Probiotics DRUG

Subjects received probiotics before radiotherapy

Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance

concurrent Hyperfractionated Radiotherapy RADIATION

Increase radiation dose on the basis of conventional radiotherapy

Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance; Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance

Immunotherapy DRUG

Adebrelimab, 1200mg，q3w，2 year

Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance; Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

Probiotics; Immunotherapy

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Xingwen Fan

CONTACT

+86 13651669687; wenxingfan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CN (1)