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Hypofractionated Radiotherapy Followed by Chemo-immunotherapy Induction Therapy

ConditionsLung Cancer, Small CellLimited-stage Small Cell Lung Cancer (LS-SCLC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ANC ≥ 1.5×109/L;

PLT ≥ 100×109/L;

HB ≥ 90 g/L;

TBIL ≤ 1.5×ULN;

Disqualifiers

Central nervous system metastasis;

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;

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Induction therapy：Adebrelimab, 1200mg, d1, q3w, 2 cycles; Maintenance therapy：Adebrelimab, 1200mg, d1, q3w, until disease progression or unbearable toxicity.

  • EC/EP

    Drug

    Chemotherapy: standard chemotherapy EC/EP

  • SBRT

    Radiation

    8Gy\*3

  • Chest radiotherapy

    Radiation

    Chest radiotherapy: conventional fractionation mode 2Gy QD total dose 60Gy or 1.5Gy BID total dose 45Gy, according to the patient's physical condition, concurrent EP or EC chemotherapy can be considered

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Arm 1Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progress Free Survival

Time frame
24months

Secondary outcomes

1

Objective response rate

Time frame
24months
2

Overall survival

Time frame
24months
3

TRAEs

Time frame
24months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: