Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases
NCT ID: NCT06953843
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
366 participants
INTERVENTIONAL
2025-07-09
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.
Group B
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart.
Group C
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
Group D
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart.
Group E
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
Group F
Benmelstobart combined with Bevacizumab and chemotherapy
For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.
Interventions
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Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart.
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart.
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
Benmelstobart combined with Bevacizumab and chemotherapy
For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. More than 3 metastatic lesions.
3. No brain metastases or stable lesions.
4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
6. Age between 18 and 75 years old.
7. Assessment by PET-CT (including FDG and FMISO, not mandatory).
8. No contraindications to immunotherapy and radiotherapy.
9. Signed the informed consent form.
Exclusion Criteria
1. Those with severe dysfunction of important vital organs (heart, liver, kidney).
2. Those accompanied by other malignant tumors.
3. Uncontrolled heart diseases or myocardial infarction within the past 6 months.
4. Those with a history of mental illness.
5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.
18 Years
75 Years
ALL
No
Sponsors
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Xinqiao Hospital of Chongqing
OTHER
Responsible Party
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Jianguo Sun
Prof
Principal Investigators
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Jianguo Sun, MD
Role: PRINCIPAL_INVESTIGATOR
the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting
Locations
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the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XQonc-023
Identifier Type: -
Identifier Source: org_study_id
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