Metastatic Malignant Solid NeoplasmPhase 2ILDR-01NCT06076135
Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Solid Tumors
A Phase 2 study testing Intestinal Low Dose Radiotherapy-1Gy and PD-1/PD-L1 Inhibitors in people with Metastatic Malignant Solid Neoplasm and Radiotherapy, run by Chuangzhen Chen at 1 site in China.
Trial summary
Preclinical and clinical studies have shown that intestinal low dose radiotherapy (ILDR) can enhance antitumor immunity and response to immune checkpoint blockade (ICB). Therefore, the investigators launch a phase Ⅱ trial to evaluate the clinical value of combining ILDR and programmed cell death-1/ -ligand 1… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Malignant Solid Neoplasm, Radiotherapy, Immune Checkpoint Blockade
- What is being tested?
- Intestinal Low Dose Radiotherapy-1Gy and PD-1/PD-L1 Inhibitors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2023to 10 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, ≤80 years, regardless of gender.
- ECOG level 0-2.
- Expected life span>3 months.
- At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria.
- Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression.
- The patient is considered ineligible for surgical treatment.
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- Patients with brain metastases assessed as clinically stable after treatment through repeated CT and/or MRI scans are eligible.
- Patients have complete clinical and pathological information.
- Any psychological, family, social or geographical conditions may hinder compliance with the research protocol.
- Patients are able to understand the informed consent form, voluntarily participate, and sign the informed consent form.
- Other indicators accord with the general inclusion criteria for clinical trials.
Who cannot join
- Patients with contraindications to radiation therapy and immunotherapy.
- Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.).
- Patients who were assessed as hyperprogressive disease (HPD).
- Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment.
- The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss).
- Accompanied by severe infections.
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- Serious liver disease (such as cirrhosis), kidney disease, respiratory disease, or chronic system diseases such as uncontrollable diabetes and hypertension; Patients who cannot tolerate radiation therapy.
- Clinical symptoms of brain metastases or meningeal metastasis.
- The patients with known allergies or allergies to the test drug ingredients.
- Substance/alcohol abuse.
- Patients who are pregnant or planning to.
- Patients participating in other clinical studies that may affect the efficacy/safety of this clinical study.
- Patients who have undergone major surgical procedures within 30 days.
- Patients who have received antibiotics, antifungal drugs, antiviral, antiparasitic drugs, or probiotics within 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, 515031
About this study
Official title: Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy and PD-1/PD-L1 Inhibitors for Metastatic Malignant Solid Tumors After Acquired Resistance to Anti-PD1/PD-L1 Treatment
Preclinical and clinical studies have shown that intestinal low dose radiotherapy (ILDR) can enhance antitumor immunity and response to immune checkpoint blockade (ICB). Therefore, the investigators launch a phase Ⅱ trial to evaluate the clinical value of combining ILDR and programmed cell death-1/ -ligand 1 (PD-1/PD-L1) inhibitors in patients with ICB refractory metastatic solid tumor.
This study is designed as a researcher-initiated, two-stage and prospective clinical trial. The target population is patients with advanced metastatic malignant solid tumors who have progressed after immunotherapy. The primary endpoints include objective response rate (ORR), disease control rate (DCR), progression free survival while receiving ILDR combined therapy (PFS2), and lesion-based abscopal response rate. The secondary endpoints include incidence of adverse events (AEs), cancer-specific survival (CSS), and overall response rate (OS).
Read more
Sixteen subjects will be enrolled in this trial. The primary objective is to evaluate the safety and efficacy of 1Gy ILDR combined with PD-1/PD-L1 inhibitors in immune-resistant metastatic malignant solid tumors, and biomarker exploration for response prediction.
Eligible patients will be subjected to 1Gy ILDR. Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as well as Immune related RECIST (iRECSIST). The extent or severity of adverse reactions will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0). Furthermore, tissue samples, stool samples, and peripheral blood samples will be collected for biomarker exploration.
- Conditions
- Metastatic Malignant Solid Neoplasm, Radiotherapy, Immune Checkpoint Blockade, Resistance to Immunotherapy
- Being tested
- Intestinal Low Dose Radiotherapy-1Gy, PD-1/PD-L1 Inhibitors
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal Low Dose Radiotherapy-1GyRadiation
1Gy ILDR will be administered to patients in a single fraction. The radiation treatment volume composes both the jejunum and ileum.
PD-1/PD-L1 InhibitorsDrug
The immunotherapy regimen is the previous ICB therapy regimen or modified by the physician in charge. PD-1/PD-L1 inhibitors will be given 1 day after ILDR at a 3-week interval.
| Study group | Role | What they receive |
|---|---|---|
| ILDR | Experimental | 1Gy/1F ILDR + PD-1/PD-L1 inhibitors. Receives: Radiation: Intestinal Low Dose Radiotherapy-1Gy; Drug: PD-1/PD-L1 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The objective effective rate of ILDR combined with PD-1/PD-L1 inhibitors in patients with metastatic malignant solid tumors after acquired resistance to immunotherapy, including complete response and partial response.
Measured: 6, 12, 24 weeks after start of ILDR.
Disease Control Rate（DCR）
The proportion of patients with optimal response to ILDR combined with PD-1/PD-L1 inhibitors.
Measured: 6, 12, 24 weeks after start of ILDR.
Progression Free Survival while Receiving ILDR combined Therapy (PFS)
The time from the date of ILDR initiation to the documented disease progression or death due to cancer.
Measured: 6, 12, 24 weeks after start of ILDR.
Lesion-based Abscopal Response Rate
The proportion of patients with tumor objective response in one or more lesions.
Measured: 6, 12, 24 weeks after start of ILDR.
Secondary outcomes (3)
Incidence of Adverse Events
The proportion of patients with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 12, 24, 48 weeks after start of ILDR.
Overall survival (OS)
The time from the date of ILDR initiation to death from any cause.
Measured: 24, 48 weeks after start of ILDR.
Cancer-specific survival (CSS)
The time from the date of ILDR initiation to death due to cancer.
Measured: 24, 48 weeks after start of ILDR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start26 Dec 2023
- Primary completion10 May 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Solid NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuangzhen Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuangzhen Chen, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076135
- Sponsor's protocol ID
- SUMC-ILDR01
- Acronym
- ILDR-01
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy and PD-1/PD-L1 Inhibitors for Metastatic Malignant Solid Tumors After Acquired Resistance to Anti-PD1/PD-L1 Treatment
- ClinicalTrials.gov ID
- NCT06076135
- Acronym / sponsor ID
- ILDR-01 / SUMC-ILDR01
- Conditions
- Metastatic Malignant Solid Neoplasm, Radiotherapy, Immune Checkpoint Blockade, Resistance to Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chuangzhen ChenUniversity, hospital or other
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preclinical and clinical studies have shown that intestinal low dose radiotherapy (ILDR) can enhance antitumor immunity and response to immune checkpoint blockade (ICB). Therefore, the investigators launch a phase Ⅱ trial to evaluate the clinical value of combining ILDR and programmed cell death-1/ -ligand 1 (PD-1/PD-L1) inhibitors in patients with ICB refractory metastatic solid tumor.
This study is designed as a researcher-initiated, two-stage and prospective clinical trial. The target population is patients with advanced metastatic malignant solid tumors who have progressed after immunotherapy. The primary endpoints include objective response rate (ORR), disease control rate (DCR), progression free survival while receiving ILDR combined therapy (PFS2), and lesion-based abscopal response rate. The secondary endpoints include incidence of adverse events (AEs), cancer-specific survival (CSS), and overall response rate (OS).
Sixteen subjects will be enrolled in this trial. The primary objective is to evaluate the safety and efficacy of 1Gy ILDR combined with PD-1/PD-L1 inhibitors in immune-resistant metastatic malignant solid tumors, and biomarker exploration for response prediction.
Eligible patients will be subjected to 1Gy ILDR. Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as well as Immune related RECIST (iRECSIST). The extent or severity of adverse reactions will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0). Furthermore, tissue samples, stool samples, and peripheral blood samples will be collected for biomarker exploration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILDR | Experimental | Radiation: Intestinal Low Dose Radiotherapy-1Gy, Drug: PD-1/PD-L1 Inhibitors1Gy/1F ILDR + PD-1/PD-L1 inhibitors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years, ≤80 years, regardless of gender.
- ECOG level 0-2.
- Expected life span>3 months.
- At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria.
- Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression.
Key exclusion criteria (14 listed)
- Patients with contraindications to radiation therapy and immunotherapy.
- Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.).
- Patients who were assessed as hyperprogressive disease (HPD).
- Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment.
- The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal Low Dose Radiotherapy-1Gy1Gy ILDR will be administered to patients in a single fraction. The radiation treatment volume composes both the jejunum and ileum. | Radiation | ILDR |
| PD-1/PD-L1 InhibitorsThe immunotherapy regimen is the previous ICB therapy regimen or modified by the physician in charge. PD-1/PD-L1 inhibitors will be given 1 day after ILDR at a 3-week interval. | Drug | ILDR |
Primary outcome
Objective Response Rate (ORR)
Time frame: 6, 12, 24 weeks after start of ILDR.
The objective effective rate of ILDR combined with PD-1/PD-L1 inhibitors in patients with metastatic malignant solid tumors after acquired resistance to immunotherapy, including complete response and partial response.
Disease Control Rate（DCR）
Time frame: 6, 12, 24 weeks after start of ILDR.
The proportion of patients with optimal response to ILDR combined with PD-1/PD-L1 inhibitors.
Progression Free Survival while Receiving ILDR combined Therapy (PFS)
Time frame: 6, 12, 24 weeks after start of ILDR.
The time from the date of ILDR initiation to the documented disease progression or death due to cancer.
Lesion-based Abscopal Response Rate
Time frame: 6, 12, 24 weeks after start of ILDR.
The proportion of patients with tumor objective response in one or more lesions.
3 secondary outcomes
Incidence of Adverse Events
Time frame: 12, 24, 48 weeks after start of ILDR.
Overall survival (OS)
Time frame: 24, 48 weeks after start of ILDR.
Cancer-specific survival (CSS)
Time frame: 24, 48 weeks after start of ILDR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intestinal Low Dose Radiotherapy-1Gy and PD-1/PD-L1 Inhibitors in people with Metastatic Malignant Solid Neoplasm and Radiotherapy, run by Chuangzhen Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 6, 12, 24 weeks after start of ILDR.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.