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NCT06949098RecruitingPhase 2

Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer

An Exploratory Study of Local Resection Combined With Chemoradiotherapy in Patients With Low/Ultra-low Early-stage Rectal Cancer With a Strong Desire to Preserve the Anus

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
22 Apr 2025
Start date
15 May 2025
Primary completion date
31 Mar 2032
Lead sponsor
Hebei Medical University Fourth Hospital
NCT number
NCT06949098

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 15 May 2025 to the primary completion date, 31 Mar 2032
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Failure to meet the above inclusion criteria
  • Impaired cognitive function or psychiatric disorders

Other

  • Patients refusing to sign informed consent
  • Patients deemed ineligible by investigators

Who the study is looking for

  • Age ≥18 years, regardless of gender
  • ECOG performance status 0-1
  • Biopsy-proven rectal adenocarcinoma
  • Distal margin of primary tumor ≤8 cm from anal verge
  • Clinical stage I (cT1-2N0M0)
  • Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation)
  • The surgeon determined a local resection was feasible
  • No contraindications to chemoradiotherapy

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Fourth Hospital of Hebei Medical University
Coordinator of this site? Confirm its status
ShijiazhuangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.