Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): … (NCT06850090) | Clinical Trial Compass
RecruitingPhase 3
Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
China210 participantsStarted 2025-07-30
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients aged between 18 and 75 years of either sex.
✓. Histologically confirmed rectal adenocarcinoma with the following conditions:
✓. Clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI.
✓. 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 \[≤5 cm from the anal verge\]).
✓. No other types of rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer.
✓. Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
✕. 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.
✕. Active autoimmune disease or history of autoimmune disease.
✕. Uncontrolled cardiac symptoms or diseases.
✕. History of other malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.