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

ConditionLimited Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Sign written informed consent before implementing any experimental procedures;

Age range: 18-80 years old;

Pathological diagnosis of small cell lung cancer;

Limited stage;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab ImmunomaintenanceExperimental treatment 3 interventions
Group B: Concurrent Hyperfractionated Radiotherapy and Adebrelimab ImmunomaintenancePlacebo comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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