Cancer PatientsFL002NCT05906329
Low-dose Radiotherapy Combined With Conventional Fractionated Radiotherapy in Lung Cancer After Immunotherapy Resistance
A study testing Low-dose radiotherapy combined with conventional fractionated radiotherapy in people with Cancer Patients, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Pre-clinical and clinical studies have shown that low-dose radiation therapy has good immune regulatory effects, activates different anti-tumor immune pathways, and regulates tumor stroma to better promote T cell infiltration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer Patients
- What is being tested?
- Low-dose radiotherapy combined with conventional fractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2022to 30 Jun 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients are able to understand the informed consent form, voluntarily participate and sign the informed consent form.
- 2. Age range from 18 to 65 years old, regardless of gender.
- 3. ECOG level 0-1; Expected life>6 months.
- 4. At least get into a liquid diet.
- 5. No history of severe allergies.
- 6. Hemoglobin ≥ 100 g/L, WBC ≥ 3.5 x10~9/L, neutrophils ≥ 1.8 x10~9/L, platelets ≥ 10 x10~9/L; AST and ALT ≤ 2.5 × normal upper limit, AKP ≤ 2.5 × normal upper limit.
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- 7. Non small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous carcinoma, adenosquamous carcinoma, sarcomatoid carcinoma) confirmed by cytology or histology.
- 8. Complete clinical data.
- 9. ≤ 10 primary and regional metastatic lymph nodes and distant metastatic lesions, and ≤ 5 organ metastases.
- 10. Malignant tumor patients with immune therapy resistance (evaluated after 6-8 weeks of treatment and no improvement in clinical symptoms) without standard treatment options.
- 11. There are measurable primary lesions, regional lymph node metastasis, and distant metastatic lesions.
Who cannot join
- 1. Missing key patient information (pathological diagnosis, radiation dose, imaging examination, previous treatment plans, etc.).
- 2. Refusal or lack of cooperation in research.
- 3. Patients who have participated in other clinical studies/trials within three months.
- 4. Patients with brain metastases.
- 5. The researcher determines that there are any patients who are not suitable to participate in the study.
- 6. Accompanied by severe infections.
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- 7. 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.
- 8. Previous occurrence of immune related toxic side effects (immune myocarditis, pneumonia, etc.).
- 9. Previous history of radiation therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)16766 Jingshi Road, Jinan City
Jinan, In Shandong Province, 250013
JIANDONG ZHANG JD ZHANG, Dr., 13583123486, zhangjd165@sina.com
About this study
Official title: A Clinical Study on Low-dose Radiotherapy Combined With Conventional Fractionated Radiotherapy in Non Small Cell Lung Cancer After Immunotherapy Resistance
Pre-clinical and clinical studies have shown that low-dose radiation therapy has good immune regulatory effects, activates different anti-tumor immune pathways, and regulates tumor stroma to better promote T cell infiltration. Conventional fractionated radiotherapy increases antigen release and presentation, and stimulates immune cells. In theory, the combination of the two can reverse immune resistance. Our study aims to clarify the efficacy and safety of low-dose radiotherapy combined with conventional fractionated radiotherapy in reversing immune therapy resistance for patients with non-small cell lung cancer, including objective response rate (ORR), progression free survival time (PFS), disease control rate (DCR), health-related quality of life assessment (HRQoL), and incidence of adverse events (AEs).
Read the detailed description
This study is a researcher initiated, prospective, single arm, open clinical study.
Patients with non-small cell lung cancer who have undergone first-line or multi-line immunotherapy and have no standard treatment option after resistance are recruited in Department of Radiotherapy in the First Affiliated Hospital of Shandong First Medical University. Patients who meet the conditions shall be treated after signing a written informed consent form. Radiotherapy localization was performed through enhanced CT, and the target area was delineated. The lesion included the primary lesion and lymph nodes with a visible short diameter of ≥ 1cm, and there was metastasis confirmed by two deputy chief physicians based on enhanced MR and PET/CT examination results.
The primary lesion, the largest metastatic lesion, or the lesion causing symptoms are selected and performed conventional fractionated radiation of 1.8-2Gy/f, 40Gy-60Gy. For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total.
The immunotherapy regimen is implemented according to the specific dose and interval of the original immunotherapy regimen, such as synchronous combination chemotherapy or anti angiogenic drug therapy.
Immunotherapy is combined with radiotherapy at a frequency of once every 3 weeks until progression.
The attending physician is responsible for developing personalized follow-up plans based on the patient's personal situation, daily diagnosis and treatment routines, and standards.
Evaluate the incidence of ORR, PFS, DCR, HRQoL, AE, and sAE according to the guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST) to evaluate the patient's degree of benefit in this trial.
Regarding the determination of immunotherapy resistance, if the tumor does not respond to initial immunotherapy and does not respond after more than 6 weeks of exposure to immune drugs, primary resistance may occur and imaging is needed to confirm the disease progression again. If two or more deputy chief physicians evaluate and determine the disease progression, immunotherapy resistance may occur. On the other hand, if the drug exposure time is more than 6 months, the tumor does not respond, and the acquired drug resistance may occur, including the new drug-resistant mutant derived from the tumor and the changes in the tumor microenvironment. The disease progress also needs to be re determined by imaging. If the disease progress is determined after the evaluation of more than two deputy chief physicians, the immunotherapy drug resistance occurs.
The quality control of all stages of clinical trials will be strictly implemented, including relevant evaluation indicators, participants, and a complete management system will be established.
- Conditions
- Cancer Patients
- Being tested
- Low-dose radiotherapy combined with conventional fractionated radiotherapy
- Keywords
- lung cancer, radiotherapy, immunotherapy resistance
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose radiotherapy combined with conventional fractionated radiotherapyRadiation
Select the primary lesion, the largest metastatic lesion, or the lesion causing symptoms, and perform routine segmentation (1.8-2Gy/f, 40Gy-60Gy). For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy resistance | Other | By using enhanced CT to locate the chest, abdomen, and pelvis, the target area was delineated. The lesion was a visible lymph node with a short diameter of ≥ 1cm, and there was metastasis confirmed by two deputy chief physicians based on enhanced MR and PET/CT examination results. Select the primary lesion, the largest metastatic lesion, or the lesion causing symptoms, and perform routine segmentation (1.8-2Gy/f, 40Gy-60Gy). For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total. The immunotherapy plan is carried out according to the specific dose and interval of the original immune plan. Usually, immunotherapy is combined with radiotherapy at a frequency of once every 3 weeks until progression. Receives: Radiation: Low-dose radiotherapy combined with conventional fractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
To evaluate the objective effective rate of low-dose radiotherapy combined with conventional fractionated radiotherapy and immunotherapy in patients with non-small cell lung cancer after immunotherapy resistance without standard regimens.
Measured: Eighteen months
Secondary outcomes (3)
PFS
To evaluate the progression-free survival (PFS) of patients with advanced malignant tumors after low-dose radiotherapy combined with conventional fractionated radiotherapy and immunotherapy without standard regimens after immunotherapy resistance.
Measured: Eighteen months
DCR
To evaluate the proportion of patients with optimal response to low-dose radiotherapy and conventional fractionated radiotherapy combined with immunotherapy to achieve complete response, partial response, or disease control after no standard regimen was available for immunotherapy resistance.
Measured: Eighteen months
HRQoL、AE、SAE
Evaluation of health related quality of life and safety of post- low-dose radiotherapy combined with conventional fractionated radiotherapy and immunotherapy in patients with non-small cell lung cancer.
Measured: Eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start31 Dec 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiandong Zhang, Qianfoshan Hospital
- Investigators
- Pingping Hu, Dr., Principal investigator, Deputy chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906329
- Sponsor's protocol ID
- YXLL-KY-2023（015）
- Acronym
- FL002
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.
PubMed 32417411
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Low-dose Radiotherapy Combined With Conventional Fractionated Radiotherapy in Non Small Cell Lung Cancer After Immunotherapy Resistance
- ClinicalTrials.gov ID
- NCT05906329
- Acronym / sponsor ID
- FL002 / YXLL-KY-2023（015）
- Conditions
- Cancer Patients
- Keywords
- lung cancer, radiotherapy, immunotherapy resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 Jun 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.
Pre-clinical and clinical studies have shown that low-dose radiation therapy has good immune regulatory effects, activates different anti-tumor immune pathways, and regulates tumor stroma to better promote T cell infiltration. Conventional fractionated radiotherapy increases antigen release and presentation, and stimulates immune cells. In theory, the combination of the two can reverse immune resistance. Our study aims to clarify the efficacy and safety of low-dose radiotherapy combined with conventional fractionated radiotherapy in reversing immune therapy resistance for patients with non-small cell lung cancer, including objective response rate (ORR), progression free survival time (PFS), disease control rate (DCR), health-related quality of life assessment (HRQoL), and incidence of adverse events (AEs).
Detailed description
This study is a researcher initiated, prospective, single arm, open clinical study.
Patients with non-small cell lung cancer who have undergone first-line or multi-line immunotherapy and have no standard treatment option after resistance are recruited in Department of Radiotherapy in the First Affiliated Hospital of Shandong First Medical University. Patients who meet the conditions shall be treated after signing a written informed consent form. Radiotherapy localization was performed through enhanced CT, and the target area was delineated. The lesion included the primary lesion and lymph nodes with a visible short diameter of ≥ 1cm, and there was metastasis confirmed by two deputy chief physicians based on enhanced MR and PET/CT examination results.
The primary lesion, the largest metastatic lesion, or the lesion causing symptoms are selected and performed conventional fractionated radiation of 1.8-2Gy/f, 40Gy-60Gy. For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total.
The immunotherapy regimen is implemented according to the specific dose and interval of the original immunotherapy regimen, such as synchronous combination chemotherapy or anti angiogenic drug therapy.
Immunotherapy is combined with radiotherapy at a frequency of once every 3 weeks until progression.
The attending physician is responsible for developing personalized follow-up plans based on the patient's personal situation, daily diagnosis and treatment routines, and standards.
Evaluate the incidence of ORR, PFS, DCR, HRQoL, AE, and sAE according to the guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST) to evaluate the patient's degree of benefit in this trial.
Regarding the determination of immunotherapy resistance, if the tumor does not respond to initial immunotherapy and does not respond after more than 6 weeks of exposure to immune drugs, primary resistance may occur and imaging is needed to confirm the disease progression again. If two or more deputy chief physicians evaluate and determine the disease progression, immunotherapy resistance may occur. On the other hand, if the drug exposure time is more than 6 months, the tumor does not respond, and the acquired drug resistance may occur, including the new drug-resistant mutant derived from the tumor and the changes in the tumor microenvironment. The disease progress also needs to be re determined by imaging. If the disease progress is determined after the evaluation of more than two deputy chief physicians, the immunotherapy drug resistance occurs.
The quality control of all stages of clinical trials will be strictly implemented, including relevant evaluation indicators, participants, and a complete management system will be established.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy resistance | Other | Radiation: Low-dose radiotherapy combined with conventional fractionated radiotherapyBy using enhanced CT to locate the chest, abdomen, and pelvis, the target area was delineated. The lesion was a visible lymph node with a short diameter of ≥ 1cm, and there was metastasis confirmed by two deputy chief physicians based on enhanced MR and PET/CT examination results. Select the primary lesion, the largest metastatic lesion, or the lesion causing symptoms, and perform routine segmentation (1.8-2Gy/f, 40Gy-60Gy). For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total. The immunotherapy plan is carried out according to the specific dose and interval of the original immune plan. Usually, immunotherapy is combined with radiotherapy at a frequency of once every 3 weeks until progression. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Patients are able to understand the informed consent form, voluntarily participate and sign the informed consent form.
- 2. Age range from 18 to 65 years old, regardless of gender.
- 3. ECOG level 0-1; Expected life>6 months.
- 4. At least get into a liquid diet.
- 5. No history of severe allergies.
Key exclusion criteria (9 listed)
- 1. Missing key patient information (pathological diagnosis, radiation dose, imaging examination, previous treatment plans, etc.).
- 2. Refusal or lack of cooperation in research.
- 3. Patients who have participated in other clinical studies/trials within three months.
- 4. Patients with brain metastases.
- 5. The researcher determines that there are any patients who are not suitable to participate in the study.
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 |
|---|---|---|
| Low-dose radiotherapy combined with conventional fractionated radiotherapySelect the primary lesion, the largest metastatic lesion, or the lesion causing symptoms, and perform routine segmentation (1.8-2Gy/f, 40Gy-60Gy). For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total. | Radiation | Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy resistance |
Primary outcome
ORR
Time frame: Eighteen months
To evaluate the objective effective rate of low-dose radiotherapy combined with conventional fractionated radiotherapy and immunotherapy in patients with non-small cell lung cancer after immunotherapy resistance without standard regimens.
3 secondary outcomes
PFS
Time frame: Eighteen months
DCR
Time frame: Eighteen months
HRQoL、AE、SAE
Time frame: Eighteen months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 32417411Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.
- 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.
Pingping Hu, Dr. principal investigator
Deputy chief physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose radiotherapy combined with conventional fractionated radiotherapy in people with Cancer Patients, run by Qianfoshan Hospital 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 9 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiandong Zhang, Dr. (13583123486 ext. 89269188, zhangjd165@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Eighteen months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05906329, which also lists 1 linked publication.
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 15 Jun 2023.