NCT06850090RecruitingPhase 3
Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 30 Jul 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT06850090
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 210
- From 30 Jul 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Cancer Hospital and Institute Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.