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

May 4, 2026 updated by: You Lu, Sichuan University

Clinical Study on the Efficacy and Safety of Radiotherapy Combined With Immunotherapy and Chemotherapy for Pre-treated Patients With Small Cell Lung Cancer and Liver Metastases

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All eligible patients will receive liver-directed radiotherapy, followed by PD-1/PD-L1 inhibitors plus chemotherapy. The systemic therapy is initiated concurrently with radiotherapy. PD-1/PD-L1 inhibitors and chemotherapeutic agents (such as Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) are administered intravenously every 3 weeks according to their approved product information. The treatment regimen consists of an initial concurrent phase of radiotherapy, immunotherapy, and chemotherapy, followed by a maintenance phase with PD-1/PD-L1 inhibitors alone until disease progression or for up to 24 months.Main Objective and Endpoint:

The primary objective is to evaluate the objective response rate (ORR) and safety of the combination therapy. The primary endpoint is the ORR, defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria, as determined by the investigator.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 75 years, with an ECOG Performance Status of 0-2.
  2. Histologically confirmed stage IV non-small cell lung cancer (NSCLC) or extensive-stage small cell lung cancer, with radiologically confirmed liver metastases (at least one measurable lesion with the longest diameter ≥ 1 cm).
  3. Prior failure (due to progression or intolerance) to platinum-based doublet chemotherapy and PD-1/PD-L1 inhibitor therapy.
  4. Adequate liver function reserve (Child-Pugh class A or B, ALT/AST ≤ 5 × ULN, total bilirubin ≤ 1.5 × ULN).
  5. Life expectancy of at least 3 months.
  6. Normal function of major organs and no severe dysfunction of the hematopoietic, cardiac, pulmonary, hepatic, renal, or bone marrow systems, or immunodeficiency diseases.
  7. Within one week prior to enrollment, bone marrow and organ function meet the following criteria:Hemoglobin ≥ 80 g/L, neutrophil count ≥ 1.5 × 10⁹/L, and platelet count ≥ 70 × 10⁹/L. Renal function: Serum creatinine ≤ 1.5 × ULN, and endogenous creatinine clearance rate ≥ 55 ml/min.Liver function: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (if liver metastases are present, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN are acceptable).
  8. Voluntarily participates and provides written informed consent.
  9. Good compliance and willingness to adhere to the study visit schedule and other protocol requirements.
  10. Willingness to provide blood and tissue samples for biomarker testing.
  11. Judged by the radiation oncologist to have no contraindications to liver radiotherapy. Patients who agree to receive immunotherapy, chemotherapy, and radiotherapy.
  12. For patients of childbearing potential: agreement to use effective contraception during the study period and for at least 6 months after the last study treatment; negative serum or urine pregnancy test within 7 days prior to study entry; and not breastfeeding. Male patients with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.

Exclusion Criteria:

  1. Presence of any active autoimmune disease or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [may be included if controlled with hormone replacement therapy]); prior liver radiotherapy or liver transplantation; history of liver cirrhosis (Fibroscan ≥ F3), portal hypertension, or hepatic encephalopathy.
  2. Congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection of the assay), or co-infection with both hepatitis B and C.
  3. Uncontrolled or significant cardiac disease, including: (a) NYHA Class II or higher heart failure; (b) Unstable angina; (c) Myocardial infarction within the past 1 year; (d) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
  4. Severe infection or serious comorbidities within 4 weeks prior to the first dose of study treatment.
  5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  6. History of other primary malignancies within the past 5 years.
  7. Known allergy to any of the trial drugs or their excipients.
  8. Pregnant or lactating women, or subjects of childbearing potential unwilling to use effective contraception during the study period.
  9. Patients with Child-Pugh class B or C liver insufficiency.
  10. Any other contraindication as determined by the investigator to preclude participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Immunotherapy
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
Drug: Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin)
Combined With immunotherapy.
Radiation: low-dose radiation
Liver-directed radiotherapy (low-dose radiation(3Gy*5d) followed by Immunotherapy
Radiation: Stereotactic Body Radiation Therapy (SBRT)
low-dose radiation(3Gy*5d) +stereotactic body radiation therapy (10Gy*3d) )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The proportion of participants who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From enrollment until first progression or death, assessed up to approximately 3 years.
The time from the date of enrollment until the first documented date of disease progression as per RECIST v1.1, or death from any cause, whichever occurs first.
From enrollment until first progression or death, assessed up to approximately 3 years.
Disease Control Rate (DCR)
Time Frame: From enrollment until the first documented date of disease progression, assessed up to 24 months.
The proportion of participants who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1.
From enrollment until the first documented date of disease progression, assessed up to 24 months.
Incidence of Adverse Events (AEs)
Time Frame: From the first dose of study treatment until 30 days after the last dose (up to approximately 25 months).
The number and percentage of participants with any adverse event, serious adverse event, and immune-related adverse event. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
From the first dose of study treatment until 30 days after the last dose (up to approximately 25 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Investigators

  • Principal Investigator: You Lu, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCLC-LM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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