Recruiting nowNot phased
What this trial is trying to do
The researchers are testing whether pelvic external-beam radiotherapy followed by high-dose-rate endorectal brachytherapy—radiation delivered from inside the rectum—can control localized rectal cancer while preserving the rectum. A patient-specific 3D-printed guide is intended to position the applicator consistently, and local shielding is intended to reduce radiation to healthy rectal wall; capecitabine may be added during external radiotherapy for people able to tolerate it.
The idea is that this approach could offer an alternative to radical surgery for people who cannot have surgery, decline it, or have technically unresectable disease, with the aim of avoiding removal of the rectum. The trial will mainly measure how many people have no detectable clinical cancer at 12 months, as well as organ preservation, regrowth, side effects, survival, quality of life, and anorectal function.
Worth knowing: This is a small, single-centre, single-arm study with no comparison group, and its main measure—clinical complete response at 12 months—is not the same as proving longer survival or permanent cancer control.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07786493 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | open label |
| Taking part | 50 people (planned) |
| Who can join | aged 18 Years to 80 Years |
| Run by | Tianjin Medical University Cancer Institute and Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy High-Dose-Rate Endorectal Brachytherapy
What it is measuring
12-Month Clinical Complete Response Rate
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
This prospective, single-center, single-arm phase II study will evaluate the efficacy, safety, and technical feasibility of an organ-preserving radiotherapy strategy for patients with localized rectal adenocarcinoma who are medically inoperable, decline radical surgery, or are considered technically unresectable without distant metastases.
Participants will receive pelvic external beam radiotherapy followed by high-dose-rate (HDR) endorectal brachytherapy. Concurrent capecitabine may be given during external beam radiotherapy to participants who are considered able to tolerate chemotherapy. During HDR brachytherapy, all participants will be treated using a patient-specific 3D-printed guide template and individualized tungsten-alloy local shielding. The guide template is designed to improve applicator positioning and treatment reproducibility, while the local shielding is intended to reduce radiation exposure to non-target rectal wall.
The study will enroll 50 participants. The primary objectives are to evaluate the 12-month clinical complete response rate and the technical completion rate of the HDR brachytherapy platform. Secondary assessments include organ preservation, local regrowth, survival outcomes, treatment-related toxicity, quality of life, and anorectal function.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07786493, registered by Tianjin Medical University Cancer Institute and Hospital on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.