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NCT Number: NCT06943235

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

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.

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Key information

Conditions

Limited Stage Small Cell Lung Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

Probiotics

Drug

Subjects received probiotics before radiotherapy

concurrent Hyperfractionated Radiotherapy

Radiation

Increase radiation dose on the basis of conventional radiotherapy

Immunotherapy

Drug

Adebrelimab, 1200mg，q3w，2 year

Primary outcomes

  1. one year progression free survival rate

    Time frame: one year

  2. Complete response rate at the end of radiotherapy for one month

    Time frame: at the end of radiotherapy for one month

Secondary outcomes

  1. One year overall survival rate

    Time frame: one year

  2. one year Survival rate without distant metastasis

    Time frame: one year

  3. Adverse reactions

    Time frame: one year

Study contacts

Contact information is provided by the study sponsor or research team.

Xingwen Fan

CONTACT

[email protected]

+86 13651669687

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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