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Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases

ConditionsLiver MetastasesNon-Small Cell Lung CancerColorectal Cancer (Diagnosis)Pancreatic Cancer MetastaticSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBing Xia

About this trial

This study aims to evaluate the effectiveness and safety of combining low-dose radiotherapy to the intestines with immune checkpoint inhibitors (ICIs) in patients with liver metastases from solid tumors.

Liver metastases often create an "immune desert" that makes immunotherapy less effective. Recent research has shown that low-dose irradiation of the gut (1 Gy) can reshape the gut microbiome and activate the immune system, potentially reversing resistance to immunotherapy.

This is a prospective, single-arm, single-center cohort study. We plan to enroll 120 patients with liver metastases from non-small cell lung cancer (NSCLC), colorectal cancer, or pancreatic cancer. All participants will receive a single low dose of radiotherapy to the intestine (1 Gy), followed by standard immune checkpoint inhibitors and chemotherapy.

The main goal of this study is to see how well the liver metastases respond to this combined treatment. We will also monitor survival, side effects, and changes in the gut bacteria and blood immune markers to understand how this treatment works. This strategy may provide a low-cost, low-toxicity new option for patients whose liver metastases have stopped responding to standard immunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female.

ECOG performance status 0-2.

Expected survival ≥ 3 months.

Cohort A: Advanced NSCLC with negative driver genes (EGFR/ALK/ROS1), disease progression during first-line platinum-based doublet chemotherapy combined with PD-1/PD-L1 inhibitors.

Disqualifiers

Contraindications to radiotherapy and immune checkpoint inhibitor therapy.

Prior unacceptable toxicity following immune checkpoint inhibitor therapy.

History of abdominopelvic radiotherapy within 6 months prior to enrollment.

Prior anti-tumor adverse events not recovered to CTCAE 5.0 Grade ≤ 1.

Trial design

Design model

Single group

Treatments tested in this trial

  • Intestinal Low-Dose Radiotherapy (ILDR)

    Radiation

    Single fraction of 1 Gy delivered to the intestine (jejunum, ileum, and mesentery) using IMRT/VMAT.

  • PD-1/PD-L1 inhibitors

    Drug

    Administered 24-72 hours after ILDR, every 3 weeks, for up to 2 years.

  • Combined Chemotherapy

    Drug

    Regimens based on tumor type: docetaxel (Cohort A), platinum-based doublet (Cohort B), or XELOX/FOLFOX/FOLFIRI/AG (Cohort C).

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: ILDR Combined With ICIs and ChemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) of Liver Metastases

Proportion of patients achieving complete response (CR) or partial response (PR) in liver metastatic lesions, as assessed by RECIST v1.1.

Time frame
Every 6 weeks (± 3 days) until disease progression, death, or up to 24 months.

Secondary outcomes

1

Overall Objective Response Rate (ORR)

Proportion of patients achieving complete response (CR) or partial response (PR) in all target lesions, assessed by RECIST v1.1.

Time frame
Every 6 weeks (± 3 days) until disease progression, death, or up to 24 months.
2

Disease Control Rate (DCR) of Liver Metastases

Proportion of patients achieving CR, PR, or stable disease (SD) in liver metastatic lesions.

Time frame
At 6, 12, and 24 weeks after ILDR.
3

Overall Disease Control Rate (DCR)

Proportion of patients achieving CR, PR, or SD in all target lesions.

Time frame
At 6, 12, 24 weeks and every 6 weeks thereafter, until disease progression, death, or up to 24 months.
4

Progression-Free Survival (PFS)

Time from the first day of treatment to disease progression or death from any cause, whichever occurs first.

Time frame
From the first day of treatment to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.

Other outcomes

Sponsors and contacts

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

Bing Xia

Lead sponsor

First People's Hospital of Hangzhou

Sponsor institution

Source ClinicalTrials.gov

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