Unresectable Malignant NeoplasmLARGE-ProtonNCT07818798
Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors
An observational study of Unresectable Malignant Neoplasm and Bulky Tumor, run by Peking University First Hospital.
Trial summary
This prospective, multicenter, observational cohort study will enroll 60 adults with unresectable larege tumors (longest diameter > 5 cm) who receive one of two treatment modes: (A) proton P-SABR, in which both the proton partial-SABR boost (course 1) and the subsequent proton CFRT (course 2) are delivered at the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Malignant Neoplasm, Bulky Tumor, Solid Tumor
- What is being tested?
- Proton P-SABR and Proton-Photon Hybrid P-SABR
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with histologically or cytologically confirmed, unresectable bulky solid tumors (at least one lesion with longest diameter > 5 cm) who present to the radiation oncology departments of the participating centers, and who elect to receive proton P-SABR (Cohort A) or proton-photon hybrid P-SABR (Cohort B). Eligible patients are enrolled consecutively after written informed consent.
Who may be able to join
- Histologically or cytologically confirmed malignancy
- At least one tumor with a longest diameter > 5 cm
- Not amenable to curative surgical resection, or patient declines surgery, or surgery contraindicated because of medical comorbidities
- Age ≥ 18 years
- ECOG performance status 0-2
- Life expectancy > 3 months
- Written informed consent
Who cannot join
- Prior radiotherapy to the same site
- Severe cardiopulmonary insufficiency precluding radiotherapy
- Concurrent other active malignancy
- Uncontrolled acute infection or bowel obstruction
- Pregnancy or breastfeeding
- Intracranial lesion
Show all 9Show fewer
- Tumor directly invading the full thickness of the esophageal, gastric or intestinal wall with active ulceration, fistula or uncontrolled risk of perforation (tumors that only abut or displace a hollow organ without full-thickness invasion are not excluded)
- Uncontrolled active tumor bleeding, or impending pathological fracture requiring orthopedic intervention
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Observational Cohort Study of Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors
This prospective, multicenter, observational cohort study will enroll 60 adults with unresectable larege tumors (longest diameter > 5 cm) who receive one of two treatment modes: (A) proton P-SABR, in which both the proton partial-SABR boost (course 1) and the subsequent proton CFRT (course 2) are delivered at the proton center; or (B) proton-photon hybrid P-SABR, in which course 1 is delivered with protons at the proton center and course 2 CFRT is delivered with photons. The primary objective is to describe, in each cohort, the incidence of treatment-related grade ≥ 3 acute and late adverse events (CTCAE v5.0). Secondary objectives are dosimetric and the 1-year local control rate (RECIST 1.1, in-field). Participants are followed for up to 5 years.
Read the detailed description
BACKGROUND Large tumors (longest diameter > 5 cm) are often unresectable and respond poorly to conventionally fractionated radiotherapy (CFRT) because of their size and hypoxic core, while normal-tissue tolerance prevents delivering stereotactic ablative radiotherapy (SABR) to the whole tumor. Partial stereotactic ablative boost radiotherapy (P-SABR) delivers a SABR boost only to the central part of a large tumor, followed by CFRT to the whole target. Proton beams, with their Bragg-peak dose fall-off, may sharpen this "onion-skin" dose distribution and further increase the biologically effective dose (BED) within the tumor core.
DESIGN This prospective, multicenter, observational cohort study will enroll 60 adults with unresectable bulky tumors (longest diameter > 5 cm) who, as part of routine care, receive one of two treatment modes: (A) proton P-SABR, in which both the proton partial-SABR boost (course 1) and the subsequent proton CFRT (course 2) are delivered at the proton center; or (B) proton-photon hybrid P-SABR, in which course 1 is delivered with protons at the proton center and course 2 CFRT is delivered with photons (IMRT/VMAT) either at the same center or at Peking University First Hospital or one of six photon sub-centers, after central review of the composite plan. Cohort membership follows the patient's own choice and care pathway; the study does not assign treatment or intervene in clinical decisions, and no formal between-cohort hypothesis testing is planned.
OUTCOMES The primary objective is to describe, in each cohort, the incidence of treatment-related grade ≥ 3 acute and late adverse events (CTCAE v5.0). Secondary objectives are dosimetric (percentage of the GTV receiving BED10 ≥ 100 Gy, PTV V95% and V100%, organ-at-risk doses) and the 1-year local control rate (RECIST 1.1, in-field). Participants are followed for up to 5 years.
- Conditions
- Unresectable Malignant Neoplasm, Bulky Tumor, Solid Tumor
- Being tested
- Proton P-SABR, Proton-Photon Hybrid P-SABR
- Keywords
- partial stereotactic ablative boost radiotherapy, P-SABR, proton therapy, proton-photon hybrid radiotherapy, bulky tumor, large tumor, stereotactic ablative radiotherapy, spatially fractionated radiotherapy, biologically effective dose, conventionally fractionated radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton P-SABRRadiation
Also called Proton partial stereotactic ablative boost radiotherapy, Proton partial-SABR boost followed by proton conventionally fractionated radiotherapy
Course 1 (proton partial-SABR boost, IMPT): CTV 1.8-3 Gy per fraction with a simultaneous boost to the boost volume within the GTV (GTVb) of 8 Gy × 3 fractions; in larger tumors the inner GTVb (GTVb shrunk by 1 cm) is further boosted to 12 Gy × 3 fractions; critical organs at risk < 3 Gy per fraction; robust optimization on the CTV. Course 2 (proton CFRT): CTV 1.8-3 Gy per fraction with robust optimization, to a cumulative PTV dose of 60-70 Gy on the summed plan, with GTVb BED10 ≥ 100 Gy. Proton dose is expressed with a constant RBE of 1.1. Both courses are delivered at Hebei Yizhou Cancer Hospital.
Proton-Photon Hybrid P-SABRRadiation
Also called Proton-photon hybrid partial stereotactic ablative boost radiotherapy, Proton partial-SABR boost followed by photon conventionally fractionated radiotherapy
Course 1 identical to Cohort A: proton partial-SABR boost (IMPT) with GTVb 8 Gy × 3 fractions and inner GTVb 12 Gy × 3 fractions, delivered at Hebei Yizhou Cancer Hospital. Course 2 (photon CFRT): IMRT/VMAT with daily CBCT recommended, PTV 1.8-3 Gy per fraction to a cumulative PTV dose of 60-70 Gy on the summed plan, with GTVb BED10 ≥ 100 Gy, delivered at Hebei Yizhou Cancer Hospital (same-center) or at Peking University First Hospital or a photon sub-center (cross-center). For cross-center participants, DICOM-RT structure, plan and dose files of both courses are reviewed by the central radiotherapy QA committee, which performs deformable registration and dose summation (MIM; proton RBE = 1.1) before course 2 starts. Target interval between courses ≤ 3 working days (maximum 7 working days).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Proton P-SABR | Participants who receive the entire P-SABR course with protons at Hebei Yizhou Cancer Hospital: course 1, proton partial stereotactic ablative boost (intensity-modulated proton therapy, IMPT); course 2, proton conventionally fractionated radiotherapy (CFRT). Planned enrollment: 30. Receives: Radiation: Proton P-SABR | |
| Cohort B: Proton-Photon Hybrid P-SABR | Participants who receive course 1 (proton partial stereotactic ablative boost, IMPT) at Hebei Yizhou Cancer Hospital, followed by course 2 photon conventionally fractionated radiotherapy (IMRT/VMAT with daily CBCT) delivered either at the same center (pathway A, same-center; planned n = 10) or at Peking University First Hospital or one of six photon sub-centers (pathway B, cross-center; planned n = 20) after central review of the composite plan. Planned enrollment: 30. Receives: Radiation: Proton-Photon Hybrid P-SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events of grade ≥ 3 (CTCAE v5.0)
Up to 5 years after completion of radiotherapy (acute events: from the first fraction of radiotherapy through 90 days after completion; late events: from day 91 after completion through 5 years)
Measured: From the first fraction of radiotherapy to the end of the study
Secondary outcomes (4)
Percentage of the gross tumor volume (GTV) receiving a biologically effective dose (BED10) ≥ 100 Gy
Volume fraction (%) of the GTV receiving BED10 ≥ 100 Gy on the composite (summed) plan, extracted from the treatment planning system (proton dose converted with RBE = 1.1; dose summation in MIM ).
Measured: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Planning target volume (PTV) coverage: V95% and V100%
Percentage of the PTV receiving ≥ 95% (V95%) and ≥ 100% (V100%) of the prescribed cumulative dose on the composite plan, reported per cohort as mean ± SD.
Measured: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Doses to organs at risk (OARs)
Dose metrics of organs at risk (e.g., spinal cord maximum dose, esophagus, lung, bowel, brachial plexus) on the composite plan, and the proportion of participants meeting each OAR dose constraint, reported per OAR and per cohort with 95% CI.
Measured: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
1-year local control (LC) rate
Local control is defined as the absence of progressive disease (RECIST 1.1) in in-field lesions; the in-field region is defined by the GTV/CTV/PTV projections exported from the treatment planning system (DICOM-RT) and confirmed by blinded central imaging review. Time to local progression is measured from the first fraction of radiotherapy. The 1-year LC rate and its Greenwood 95% CI are estimated per cohort with the Kaplan-Meier method; no between-cohort test is performed.
Measured: 12 months after the first fraction of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-shu Gao, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818798
- Sponsor's protocol ID
- LARGE-Proton-001
- Acronym
- LARGE-Proton
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because of Chinese regulations on health data and human genetic resources. De-identified data may be shared with qualified researchers on reasonable request to the principal investigator, subject to ethics committee approval.
Publications
Bai Y, Gao XS, Qin SB, Chen JY, Su MM, Liu Q, Qin XB, Ma MW, Zhao B, Gu XB, Xie M, Cui M, Qi X, Li XY. Partial stereotactic ablative boost radiotherapy in bulky non-small cell lung cancer: a retrospective study. Onco Targets Ther. 2018 May 8;11:2571-2579. doi: 10.2147/OTT.S159538. eCollection 2018.
PubMed 29780250Bai Y, Gao X, Qin S, Li S, Ma M, Cao X, Lyu F, Chen J, Qi X, Liu S, Gao Y, Li H, Li X, Li X, Ren X, Huang L. Partial Stereotactic Ablative Radiotherapy Boost Before Conventional Radiotherapy (P-SABR) for Large (> 5 cm) Unresectable Stage III Nonsmall Cell Lung Cancer. Thorac Cancer. 2025 Jan;16(2):e15514. doi: 10.1111/1759-7714.15514. Epub 2024 Dec 14.
PubMed 39673459
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Cohort Study of Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors
- ClinicalTrials.gov ID
- NCT07818798
- Acronym / sponsor ID
- LARGE-Proton / LARGE-Proton-001
- Conditions
- Unresectable Malignant Neoplasm, Bulky Tumor, Solid Tumor
- Keywords
- partial stereotactic ablative boost radiotherapy, P-SABR, proton therapy, proton-photon hybrid radiotherapy, bulky tumor, large tumor, stereotactic ablative radiotherapy, spatially fractionated radiotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Sep 2026 (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.
This prospective, multicenter, observational cohort study will enroll 60 adults with unresectable larege tumors (longest diameter > 5 cm) who receive one of two treatment modes: (A) proton P-SABR, in which both the proton partial-SABR boost (course 1) and the subsequent proton CFRT (course 2) are delivered at the proton center; or (B) proton-photon hybrid P-SABR, in which course 1 is delivered with protons at the proton center and course 2 CFRT is delivered with photons. The primary objective is to describe, in each cohort, the incidence of treatment-related grade ≥ 3 acute and late adverse events (CTCAE v5.0). Secondary objectives are dosimetric and the 1-year local control rate (RECIST 1.1, in-field). Participants are followed for up to 5 years.
Detailed description
BACKGROUND Large tumors (longest diameter > 5 cm) are often unresectable and respond poorly to conventionally fractionated radiotherapy (CFRT) because of their size and hypoxic core, while normal-tissue tolerance prevents delivering stereotactic ablative radiotherapy (SABR) to the whole tumor. Partial stereotactic ablative boost radiotherapy (P-SABR) delivers a SABR boost only to the central part of a large tumor, followed by CFRT to the whole target. Proton beams, with their Bragg-peak dose fall-off, may sharpen this "onion-skin" dose distribution and further increase the biologically effective dose (BED) within the tumor core.
DESIGN This prospective, multicenter, observational cohort study will enroll 60 adults with unresectable bulky tumors (longest diameter > 5 cm) who, as part of routine care, receive one of two treatment modes: (A) proton P-SABR, in which both the proton partial-SABR boost (course 1) and the subsequent proton CFRT (course 2) are delivered at the proton center; or (B) proton-photon hybrid P-SABR, in which course 1 is delivered with protons at the proton center and course 2 CFRT is delivered with photons (IMRT/VMAT) either at the same center or at Peking University First Hospital or one of six photon sub-centers, after central review of the composite plan. Cohort membership follows the patient's own choice and care pathway; the study does not assign treatment or intervene in clinical decisions, and no formal between-cohort hypothesis testing is planned.
OUTCOMES The primary objective is to describe, in each cohort, the incidence of treatment-related grade ≥ 3 acute and late adverse events (CTCAE v5.0). Secondary objectives are dosimetric (percentage of the GTV receiving BED10 ≥ 100 Gy, PTV V95% and V100%, organ-at-risk doses) and the 1-year local control rate (RECIST 1.1, in-field). Participants are followed for up to 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Proton P-SABR | – | Radiation: Proton P-SABRParticipants who receive the entire P-SABR course with protons at Hebei Yizhou Cancer Hospital: course 1, proton partial stereotactic ablative boost (intensity-modulated proton therapy, IMPT); course 2, proton conventionally fractionated radiotherapy (CFRT). Planned enrollment: 30. |
| Cohort B: Proton-Photon Hybrid P-SABR | – | Radiation: Proton-Photon Hybrid P-SABRParticipants who receive course 1 (proton partial stereotactic ablative boost, IMPT) at Hebei Yizhou Cancer Hospital, followed by course 2 photon conventionally fractionated radiotherapy (IMRT/VMAT with daily CBCT) delivered either at the same center (pathway A, same-center; planned n = 10) or at Peking University First Hospital or one of six photon sub-centers (pathway B, cross-center; planned n = 20) after central review of the composite plan. Planned enrollment: 30. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with histologically or cytologically confirmed, unresectable bulky solid tumors (at least one lesion with longest diameter > 5 cm) who present to the radiation oncology departments of the participating centers, and who elect to receive proton P-SABR (Cohort A) or proton-photon hybrid P-SABR (Cohort B). Eligible patients are enrolled consecutively after written informed consent.
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed malignancy
- At least one tumor with a longest diameter > 5 cm
- Not amenable to curative surgical resection, or patient declines surgery, or surgery contraindicated because of medical comorbidities
- Age ≥ 18 years
- ECOG performance status 0-2
Key exclusion criteria (9 listed)
- Prior radiotherapy to the same site
- Severe cardiopulmonary insufficiency precluding radiotherapy
- Concurrent other active malignancy
- Uncontrolled acute infection or bowel obstruction
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Proton P-SABRAlso: Proton partial stereotactic ablative boost radiotherapy, Proton partial-SABR boost followed by proton conventionally fractionated radiotherapyCourse 1 (proton partial-SABR boost, IMPT): CTV 1.8-3 Gy per fraction with a simultaneous boost to the boost volume within the GTV (GTVb) of 8 Gy × 3 fractions; in larger tumors the inner GTVb (GTVb shrunk by 1 cm) is further boosted to 12 Gy × 3 fractions; critical organs at risk < 3 Gy per fraction; robust optimization on the CTV. Course 2 (proton CFRT): CTV 1.8-3 Gy per fraction with robust optimization, to a cumulative PTV dose of 60-70 Gy on the summed plan, with GTVb BED10 ≥ 100 Gy. Proton dose is expressed with a constant RBE of 1.1. Both courses are delivered at Hebei Yizhou Cancer Hospital. | Radiation | Cohort A: Proton P-SABR |
| Proton-Photon Hybrid P-SABRAlso: Proton-photon hybrid partial stereotactic ablative boost radiotherapy, Proton partial-SABR boost followed by photon conventionally fractionated radiotherapyCourse 1 identical to Cohort A: proton partial-SABR boost (IMPT) with GTVb 8 Gy × 3 fractions and inner GTVb 12 Gy × 3 fractions, delivered at Hebei Yizhou Cancer Hospital. Course 2 (photon CFRT): IMRT/VMAT with daily CBCT recommended, PTV 1.8-3 Gy per fraction to a cumulative PTV dose of 60-70 Gy on the summed plan, with GTVb BED10 ≥ 100 Gy, delivered at Hebei Yizhou Cancer Hospital (same-center) or at Peking University First Hospital or a photon sub-center (cross-center). For cross-center participants, DICOM-RT structure, plan and dose files of both courses are reviewed by the central radiotherapy QA committee, which performs deformable registration and dose summation (MIM; proton RBE = 1.1) before course 2 starts. Target interval between courses ≤ 3 working days (maximum 7 working days). | Radiation | Cohort B: Proton-Photon Hybrid P-SABR |
Primary outcome
Incidence of treatment-related adverse events of grade ≥ 3 (CTCAE v5.0)
Time frame: From the first fraction of radiotherapy to the end of the study
Up to 5 years after completion of radiotherapy (acute events: from the first fraction of radiotherapy through 90 days after completion; late events: from day 91 after completion through 5 years)
4 secondary outcomes
Percentage of the gross tumor volume (GTV) receiving a biologically effective dose (BED10) ≥ 100 Gy
Time frame: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Planning target volume (PTV) coverage: V95% and V100%
Time frame: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Doses to organs at risk (OARs)
Time frame: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
1-year local control (LC) rate
Time frame: 12 months after the first fraction of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 29780250Bai Y, Gao XS, Qin SB, Chen JY, Su MM, Liu Q, Qin XB, Ma MW, Zhao B, Gu XB, Xie M, Cui M, Qi X, Li XY. Partial stereotactic ablative boost radiotherapy in bulky non-small cell lung cancer: a retrospective study. Onco Targets Ther. 2018 May 8;11:2571-2579. doi: 10.2147/OTT.S159538. eCollection 2018.
- Results publication: PubMed 39673459Bai Y, Gao X, Qin S, Li S, Ma M, Cao X, Lyu F, Chen J, Qi X, Liu S, Gao Y, Li H, Li X, Li X, Ren X, Huang L. Partial Stereotactic Ablative Radiotherapy Boost Before Conventional Radiotherapy (P-SABR) for Large (> 5 cm) Unresectable Stage III Nonsmall Cell Lung Cancer. Thorac Cancer. 2025 Jan;16(2):e15514. doi: 10.1111/1759-7714.15514. Epub 2024 Dec 14.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because of Chinese regulations on health data and human genetic resources. De-identified data may be shared with qualified researchers on reasonable request to the principal investigator, subject to ethics committee approval.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Malignant Neoplasm and Bulky Tumor, run by Peking University First Hospital.
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 7 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianshu Gao, MD, PhD (010-83575239, doctorgaoxs@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events of grade ≥ 3 (CTCAE v5.0) (time frame: From the first fraction of radiotherapy to the end of the study). 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 NCT07818798, which also lists 2 linked publications.
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 14 Sep 2026.