Actively Recruiting
Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-28
210
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant fluoropyrimidine-based chemoradiotherapy followed by total mesorectal excision (TME) is the standard of care for locally advanced rectal cancer (LARC); however, pathologic complete response (pCR) rates are low. Trifluridine/tipiracil (TAS-102) is a new oral anti-tumor oral formulation of nucleoside analogue, trifluridine (FTD), and a thymidine phosphorylase inhibitor, tipiracil (TPI). Previous studies have shown that TAS-102 has shown clinically relevant activity after fluoropyrimidine failure in colorectal cancer and may thus be of increased efficacy compared with current standard capecitabine chemoradiation. Also, a phase 2 trials conducted by our team have demonstrated that neoaduvant TAS-102 concurrent with long-course radiotherapy could lead to a high pCR rate of 32% with acceptable toxicity for LARC patients. Herein, we will conduct this multicenter, randomized controlled, phase III trial to explore the safety and efficacy benefit of TAS-102 concurrent with long-course radiotherapy for LARC.
CONDITIONS
Official Title
Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 75 years of either sex.
- Histologically confirmed rectal adenocarcinoma with clinical stage II (T3-4, N-) or III (any T, N+) determined by MRI.
- Tumor located within 12 cm from the anal margin with at least one high-risk factor such as extramural vascular invasion, mesorectal fascia involvement, cT4, cN2, lateral lymph nodes, tumor deposit, or tumor in lower rectum (\u22645 cm from anal verge).
- No other types of rectal cancer or synchronous colon cancer.
- Presence of measurable lesions meeting RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Estimated life expectancy greater than 6 months.
You will not qualify if you...
- Patients with dMMR or MSI-H status.
- Unexplained myelosuppression.
- Evidence of distant metastasis or inguinal lymph node metastasis based on chest and abdominal CT or whole-body PET-CT scans.
- Active autoimmune disease or history of autoimmune disease.
- Uncontrolled cardiac symptoms or diseases.
- History of other malignancies except cured basal cell carcinoma of the skin and cervical carcinoma in situ.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jinbo Yue, Docter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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