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Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue

NCT ID NCT07818798

Disease control Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are observing two ways of giving radiation to adults with solid tumors larger than 5 cm that cannot be removed by surgery. One group receives a proton boost followed by standard proton radiation; the other receives the proton boost followed by photon radiation. The study tracks serious side effects over five years and measures how well the radiation controls the tumor in the treated area after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
proton and proton-photon hybrid partial stereotactic ablative boost radiotherapy
What this could lead to
If the approach proves safe and effective, it could offer a way to deliver high radiation doses to large tumors that surgeons cannot remove, while sparing nearby healthy organs.
What could go wrong
This is a small observational study of 60 people with no comparison group, so it cannot prove the treatment works better than standard radiotherapy. Proton therapy is costly and not widely available, and large tumors near critical organs may still cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bulky tumor Solid tumor Unresectable malignant neoplasm

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

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