Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases

Sponsor
Sichuan University
Study ID
NCT07258147
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Lung Cancer (SCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Immunotherapy — DRUG
    Combined With Chemotherapy( (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) ). Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) or low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) ) followed by Immunotherapy
  • Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) — DRUG
    Combined With immunotherapy.
  • low-dose radiation — RADIATION
    Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) followed by Immunotherapy
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) )

Study Details

This is clinical trial evaluating the safety and efficacy of radiotherapy combined with immunotherapy and chemotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) and liver metastases.

Key Dates

Start date
Oct 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation therapy combined with immunotherapy and chemotherapy group
    Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) or low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) ) followed by immunotherapy combined with chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) administered systemically every 3 weeks. Immunotherapy is continued as maintenance therapy until disease progression or for up to 24 months.

Primary Outcome Measure

ORR [ Time Frame: From date of enrollment until the first documented date of disease progression or death from any cause (whichever occurs first), assessed up to 24 months. ]

Central Contacts