Probiotics plus intensified hyperfractionated chemoradiation with adebrelimab maintenance for limited-stage small cell lung cancer
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)
Run by Fudan University · NCT06943235 · Data updated 2026-11-12
This trial tests whether adding probiotics and an intensified hyperfractionated radiotherapy plan to chemo, followed by adebrelimab maintenance, helps people with limited-stage small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 25, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT06943235 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (18–80) with pathologically confirmed limited-stage small cell lung cancer, ECOG performance status 0–1, expected survival >3 months, and who have had no more than two prior chemotherapy (±immunotherapy) cycles and no prior chest radiotherapy.
✕Probably not a fit
Patients with progressive disease after two induction treatments, severe lung disease (e.g., emphysema, interstitial changes, COPD), resting oxygen <93%, prior chest radiotherapy, or recent other malignancies are unlikely to benefit or be ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2, single-center study enrolls adults with limited-stage small cell lung cancer (ECOG 0-1) who have received no more than two rounds of chemotherapy (with or without immunotherapy). Participants receive concurrent hyperfractionated radiotherapy with a simultaneous integrated boost together with chemotherapy and daily probiotics, followed by adebrelimab monoclonal antibody as maintenance immunotherapy. The study will track tumor control, progression-free and overall survival, and treatment-related toxicities to characterize safety and activity. All treatment and follow-up are conducted at Fudan University Shanghai Cancer Center.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control and survival for patients with limited-stage small cell lung cancer while maintaining acceptable side effects.
How similar studies have gone: Maintenance immunotherapy after chemoradiation (for example the ADRIATIC results) has shown promise, but combining intensified hyperfractionated radiotherapy with probiotics and adebrelimab is a novel approach that has not been widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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;
Where it's running
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Xingwen Fan
- Email: wenxingfan@126.com
- Phone: +86 13651669687
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.