Neoadjuvant treatment for rectal cancer using TAS-102 or capecitabine

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

This phase III trial aims to compare the efficacy and safety of TAS-102, a new oral anti-tumor agent, with the standard treatment of capecitabine in patients with locally advanced rectal cancer. Participants will receive neoadjuvant chemoradiotherapy followed by total mesorectal excision. The study seeks to improve the low rates of pathologic complete response observed with current therapies. By evaluating the outcomes of both treatment regimens, the trial hopes to identify a more effective approach for enhancing tumor response and preserving anal function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged between 18 and 75 years of either sex.
2. Histologically confirmed rectal adenocarcinoma with the following conditions:

   1. Clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI.
   2. The tumor is located within 12 cm from the anal margin, with at least one high-risk factors (ie, extramural vascular invasion \[EMVI+\], mesorectal fascia involved \[MRF+\], cT4, cN2, lateral lymph nodes, tumor deposit, or tumor located in the lower rectum \[≤5 cm from the anal verge\]).
3. No other types of rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer.
4. Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6. Estimated life expectancy \> 6 months.

Exclusion Criteria:

1. Patients of dMMR or MSI-H status.
2. Unexplained myelosuppression.
3. Evidence of distant metastasis and inguinal lymph node metastasis based on comprehensive chest and abdominal CT or whole-body PET-CT scans. Retroperitoneal lymph nodes above the iliac vessel bifurcation are considered distant metastasis.
4. Active autoimmune disease or history of autoimmune disease.
5. Uncontrolled cardiac symptoms or diseases.
6. History of other malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jinbo Yue, Docter — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, Docter
• Email: jbyue@sdfmu.edu.cn
• Phone: 0531-67626442

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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.