Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 80

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment60 (estimated)
SponsorFudan University
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedApril 25, 2025
Main results expectedApril 30, 2027
Study endsDecember 30, 2027
Registry record updatedFebruary 11, 2026
Trial IDNCT06943235 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

  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.