Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

New treatment approach for advanced rectal cancer

Official title: Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer

Run by Sun Yat-sen University · NCT05228431 · Data updated 2026-11-12

This study is testing a new treatment plan for people with advanced rectal cancer to see if a gentler approach can still be effective while causing fewer side effects.

More Rectal Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment121 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedMarch 2, 2022
Main results expectedMay 1, 2027
Study endsMay 1, 2028
Registry record updatedApril 22, 2024
Trial IDNCT05228431 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 to 75 with confirmed rectal adenocarcinoma at clinical stage T3-4 or T any N1 without metastasis.

Probably not a fit

Patients with multiple primary tumors or those experiencing cachexia may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a modified sandwich therapeutic regimen for patients with locally advanced rectal cancer. The study aims to optimize the treatment by reducing the intensity of postoperative chemotherapy while still utilizing neoadjuvant chemoradiotherapy. The goal is to improve both short-term and long-term efficacy while minimizing the side effects associated with traditional treatment methods. Participants will receive a combination of XELOX, Capecitabine monotherapy, and radiation as part of their treatment plan.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced toxicity for patients with advanced rectal cancer.

How similar studies have gone: While traditional approaches have been used, this modified regimen represents a novel approach that has not been extensively tested in previous studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Pathological confirmed rectal adenocarcinoma.

Clinical stage T3-4 or T any N1.With or without MRF positivity, with or without EMVI positivity, R0 resection is estimated.

No metastasis

No signs of intestinal obstruction; or intestinal obstruction has been relieved after proximal colostomy surgery.

Age ranged from 18 to 75

No previous radiotherapy,surgery and chemotherapy.

Exclusion Criteria:

Multiple primary tumor

Cachexy

Where it's running

  • Zhenhai Lu
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.