Hypofractionated Radiotherapy Followed by Chemo-immunotherapy Induction Therapy (NCT06914050) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Hypofractionated Radiotherapy Followed by Chemo-immunotherapy Induction Therapy
30 participantsStarted 2025-04
Plain-language summary
Radiotherapy can activate local and systemic immune responses through a variety of mechanisms, which can enhance anti-tumor immune effects. The dose fractionation pattern of radiotherapy has an important influence on the occurrence of immune-induced effects. Stereotactic body radiation therapy (SBRT) has obvious advantages in activating interferon effects and inducing abscopal effects. SBRT combined with immunity can enhance the abscopal effect induced by radiotherapy and play a synergistic role. The 8Gy×3 fractionation scheme is currently the most widely used stereotactic radiotherapy scheme. Because we conducted this study, the primary lesion received large-fraction partial tumor irradiation and then received adebrelimab combined with chemotherapy induction treatment for 2 cycles, followed by sequential chest radiotherapy for the treatment of limited-stage small cell lung cancer, to explore the effectiveness and safety.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Routine blood tests must meet the following criteria (no blood transfusion, no use of hematopoietic factors, and no use of drug correction within 14 days):
✓. ANC ≥ 1.5×109/L;
✓. PLT ≥ 100×109/L;
✓. HB ≥ 90 g/L;
✓. Biochemical tests must meet the following criteria:
✕. Any active autoimmune disease or history of autoimmune disease (including, but not limited to: moderate interstitial pneumonia and above, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis; patients with vitiligo or childhood asthma that has completely resolved and does not require any intervention as an adult can be included; patients who require bronchodilators for medical intervention are not included;
What they're measuring
1
Progress Free Survival
Timeframe: 24months
Trial details
NCT IDNCT06914050
SponsorTianjin Medical University Cancer Institute and Hospital
✕. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C, active pulmonary tuberculosis;
✕. Immunosuppressive drugs have been used within 14 days before the first use of study drugs, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e. no more than 10 mg/day prednisone or its equivalent);
✕. Vaccination with live attenuated vaccine within 4 weeks before the first dose or planned during the study;
✕. Suffering from other malignant tumors in the past 3 years;
✕. Evidence of past or current pulmonary fibrosis, interstitial pneumonia (grade II or above), pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severe lung function impairment;