Can 3D-Printed shields make radiation a cure for rectal cancer without surgery?
NCT ID NCT07786493
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial tests a new way to treat rectal cancer without surgery. People with localized rectal cancer who cannot have or refuse surgery will receive external beam radiation followed by a high-dose internal radiation boost, using a 3D-printed guide and tungsten shielding to protect healthy tissue. The goal is to see if this approach can achieve a complete response at 12 months, preserving the rectum and avoiding the need for a colostomy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-dose-rate endorectal brachytherapy with a 3D-printed guide template and tungsten-alloy shielding, plus external beam radiotherapy and optional capecitabine
- What this could lead to
- If successful, this could offer a non-surgical cure for rectal cancer, allowing patients to avoid permanent colostomy and preserve their rectum.
- What could go wrong
- This is an early-phase study with a small number of patients. The treatment may not achieve complete response in all, and there are risks of radiation toxicity or local regrowth.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age 18-80 years. 2. Histologically confirmed rectal adenocarcinoma. 3. Clinical stage cT2-4, any N, M0. 4. Patients who are elderly or frail, medically unsuitable for radical surgery, refuse radical surgery, or are considered by a multidisciplinary team (MDT) to have disease for which safe R0 resection is technically difficult. 5. Considered by the MDT and investigators to be suitable for a definitive non-operative treatment strategy. 6. ECOG performance status 0-2; patients with ECOG performance status 3 may be eligible if considered by the MDT to be able to tolerate the study treatment. 7. Estimated life expectancy of at least 6 months. 8. Considered suitable for pelvic external beam radiotherapy and HDR endorectal brachytherapy. 9. Tumor location, endorectal access, and local anatomy suitable for HDR brachytherapy using the individualized 3D-printed guide template. 10. Adequate hematologic, hepatic, and renal function for the planned treatment. 11. Ability to understand the study requirements and provide written informed consent. Exclusion Criteria: 1. Distant metastatic disease or disease considered unsuitable for definitive local non-operative treatment. 2. Prior definitive pelvic radiotherapy. 3. Intestinal perforation, complete bowel obstruction, uncontrolled active bleeding, or severe active infection. 4. Anatomical or clinical conditions precluding HDR endorectal brachytherapy or use of the individualized guide template/local shielding platform. 5. Inflammatory bowel disease. 6. Severe uncontrolled cardiopulmonary disease, significant bone marrow suppression, or severe hepatic or renal dysfunction. 7. Pregnancy or breastfeeding. 8. Concurrent participation in another clinical trial that may interfere with evaluation of the study treatment or endpoints. 9. Any other condition considered by the investigator to make the patient unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
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