Recruiting nowPhase 2
| Registry number | NCT06949098 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 60 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Hebei Medical University Fourth Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Local Tumor Resection
- Radiotherapy Radiotherapy
- Drug Chemotherapy
What it is measuring
5-year DFS 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.
What this trial is trying to do
The researchers are testing whether removing only the rectal tumour locally, followed by chemotherapy and radiotherapy, can control early-stage low or ultra-low rectal cancer without the more extensive surgery often used for these tumours. The trial asks whether this treatment sequence can keep the cancer from returning or spreading after treatment.
The hoped-for advantage is avoiding or reducing the need for major rectal surgery while still maintaining cancer control. The main measure is 5-year disease-free survival (DFS), meaning how many people are alive without signs of the cancer five years after treatment.
Worth knowing: This is a small, single-centre, single-arm Phase 2 trial with no comparison group, so it cannot directly show whether the approach is better than standard surgery.
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.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low/ultra-low rectal cancer. The study plans to enroll 60 patients with T1-2N0M0 low/ultra-low rectal cancer.
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 years, regardless of gender
2. ECOG performance status 0-1
3. Biopsy-proven rectal adenocarcinoma
4. Distal margin of primary tumor ≤8 cm from anal verge
5. Clinical stage I (cT1-2N0M0)
6. Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation)
7. The surgeon determined a local resection was feasible
8. No contraindications to chemoradiotherapy
Exclusion Criteria
1. Failure to meet the above inclusion criteria
2. Patients refusing to sign informed consent
3. Impaired cognitive function or psychiatric disorders
4. Patients deemed ineligible by investigators
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 NCT06949098, registered by Hebei Medical University Fourth 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.