Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotics, concurrent Hyperfractionated Radiotherapy, Immunotherapy.
- Who it may be relevant to
- Registry conditions: Limited Stage Small Cell Lung Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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
- Drug Probiotics
Subjects received probiotics before radiotherapy - Radiation concurrent Hyperfractionated Radiotherapy
Increase radiation dose on the basis of conventional radiotherapy - Drug Immunotherapy
Adebrelimab, 1200mg，q3w，2 year
Primary outcome measures
- one year progression free survival rate [Time frame: one year]
- Complete response rate at the end of radiotherapy for one month [Time frame: at the end of radiotherapy for one month]
Secondary outcome measures (3)
- One year overall survival rate [Time frame: one year]
- one year Survival rate without distant metastasis [Time frame: one year]
- Adverse reactions [Time frame: one year]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06943235 · 2503317-7