Limited Stage Small Cell Lung CancerPhase 2NCT06943235
Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)
A Phase 2 study testing Probiotics, concurrent Hyperfractionated Radiotherapy and Immunotherapy in people with Limited Stage Small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Limited Stage Small Cell Lung Cancer
- What is being tested?
- Probiotics, concurrent Hyperfractionated Radiotherapy and Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
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)
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.
- Conditions
- Limited Stage Small Cell Lung Cancer
- Being tested
- Probiotics, concurrent Hyperfractionated Radiotherapy, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDrug
Subjects received probiotics before radiotherapy
concurrent Hyperfractionated RadiotherapyRadiation
Increase radiation dose on the basis of conventional radiotherapy
ImmunotherapyDrug
Adebrelimab, 1200mg，q3w，2 year
| Study group | Role | What they receive |
|---|---|---|
| Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance | Experimental | Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year. Receives: Drug: Probiotics; Radiation: concurrent Hyperfractionated Radiotherapy; Drug: Immunotherapy |
| Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance | Placebo comparator | Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year. Receives: Radiation: concurrent Hyperfractionated Radiotherapy; Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
one year progression free survival rate
Measured: one year
Complete response rate at the end of radiotherapy for one month
Measured: at the end of radiotherapy for one month
Secondary outcomes (3)
One year overall survival rate
Measured: one year
one year Survival rate without distant metastasis
Measured: one year
Adverse reactions
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start25 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingwen Fan, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943235
- Sponsor's protocol ID
- 2503317-7
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06943235
- Acronym / sponsor ID
- 2503317-7
- Conditions
- Limited Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance | Experimental | Drug: Probiotics, Radiation: concurrent Hyperfractionated Radiotherapy, Drug: ImmunotherapyChest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year. |
| Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance | Placebo comparator | Radiation: concurrent Hyperfractionated Radiotherapy, Drug: ImmunotherapyChest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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；
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsSubjects received probiotics before radiotherapy | Drug | Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance |
| concurrent Hyperfractionated RadiotherapyIncrease radiation dose on the basis of conventional radiotherapy | Radiation | Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance, Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance |
| ImmunotherapyAdebrelimab, 1200mg，q3w，2 year | Drug | Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance, Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotics, concurrent Hyperfractionated Radiotherapy and Immunotherapy in people with Limited Stage Small Cell Lung Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingwen Fan (+86 13651669687, wenxingfan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year progression free survival rate (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.