Response-adapted total neoadjuvant therapy guided by induction chemotherapy to enable a watch-and-wait approach for low rectal cancer

Is this trial a fit for you?

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

What this trial studies

The study combines retrospective and prospective cohorts of patients with mid-to-low rectal adenocarcinoma treated at West China Hospital who complete induction chemotherapy and total neoadjuvant therapy (TNT). Eligible patients meet early- to intermediate-risk criteria (cT1-3abN0-1M0, pMMR/MSS, tumor ≤5 cm from the anal verge, ≤2/3 circumference) and must show a treatment response after at least two cycles of XELOX (≥30% tumor length reduction). Patients are followed with serial imaging and clinical exams to record organ preservation (watch-and-wait) rates, patterns of recurrence, and the need for salvage surgery. Functional recovery and quality-of-life outcomes are compared to historical outcomes after radical surgery to preliminarily evaluate feasibility of non-surgical management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18-80 years; no restriction on sex.
* Histologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing pMMR/MSS status.
* Tumor characteristics assessed by chest-abdominal CT, rectal ultrasound, and MRI meeting all of the following criteria:

  1. The lower edge of the tumor is ≤5 cm from the anal verge as measured by digital rectal examination or MRI;
  2. Clinical stage cT1-3abN0-1M0 (for cT1N0, patients suitable for endoscopic resection are excluded);
  3. MRF (-) (\>1 mm), EMVI (±);
  4. Negative lateral lymph nodes and \<7 mm in size;
  5. Maximum tumor length ≤5 cm;
  6. Tumor circumference involvement ≤2/3.
* After receiving at least two cycles of induction chemotherapy with the XELOX regimen, MRI assessment shows treatment response (tumor length reduced by ≥30% compared with baseline).
* Completion of total neoadjuvant therapy (TNT), including long-course chemoradiotherapy and consolidation chemotherapy (radiotherapy: 25-28 fractions; chemotherapy: 6-8 cycles).
* (For the prospective cohort) Provision of written informed consent for participation in this observational study.

Exclusion Criteria:

* Patients with a history of, or concurrent, other malignant tumors (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
* Patients with severely incomplete clinical data that preclude effective evaluation;
* (For the prospective cohort) Patients who refuse to provide written informed consent.

Where it's running

• West China hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Ziqiang Wang, M.D.
• Email: wangziqiang@scu.edu.cn
• Phone: +86 18980602028

Similar studies

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

• Single vs. double stapling and purse-string techniques after rectal cancer surgery

  This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.

  Recruiting Alexandria University · Alexandria · NCT07929415

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Rectal cancer registry to track real-world treatments and outcomes

  This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.

  Recruiting at 2 sites Austrian Breast & Colorectal Cancer Study Group · Wiener Neustadt, Lower Austria and 5 other locations · NCT07780305

• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

  This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.

  Recruiting Biruni University · Istanbul · NCT07732894

• Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer

  This study tests whether close follow-up alone after local removal of early rectal cancer can match the cancer control of adding chemoradiotherapy, while reducing treatment-related side effects.

  Recruiting at 2 sites Medical University of Gdansk · Limoges and 2 other locations · NCT07669298

• Different-Dose Short-Course Radiotherapy With CAPOX, PD-1 Blockade, and IL-2 in Locally Advanced Rectal Cancer

  This phase II trial tests whether a low-dose short-course radiotherapy combined with CAPOX, a PD-1 blocker, and IL-2 works as well as the standard-dose short-course approach in patients with locally advanced rectal cancer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07646639

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.