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

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Limited Stage Small Cell Lung Cancer

Treatments: Drug: Probiotics; Radiation: concurrent Hyperfractionated Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06943235

2503317-7

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance

Experimental group

Description:

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.

Treatment:

Radiation: concurrent Hyperfractionated Radiotherapy

Drug: Probiotics

Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance

Placebo Comparator group

Description:

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.

Treatment:

Radiation: concurrent Hyperfractionated Radiotherapy