Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial

Recruiting now · Phase 3

Conditions studied: Rectal Cancer, Rectal Cancer Patients

In brief

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.

Key facts

Study ID

NCT06850090

Run by

Shandong Cancer Hospital and Institute

People needed

210

Starts

2025-07-30

Expected to finish

2028-06-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Estimated life expectancy > 6 months.

You may not qualify if…

• Patients of dMMR or MSI-H status.
• Unexplained myelosuppression.
• 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.

Where it is running

• Shandong Cancer Hospital and Institute — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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