TAS-102 Versus Capecitabine With Radiotherapy Before Surgery for Rectal Cancer
Compares TAS-102 with capecitabine alongside radiotherapy before surgery in people with rectal cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
Key facts
- Where
- Jinan, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rectal adenocarcinoma that has grown locally (stage II or III) and has not spread to distant organs. It compares two chemoradiotherapy drugs, TAS-102 and capecitabine, given before surgery.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Rectal adenocarcinoma, clinical stage II (T3-4, N-) or III (any T, N+) on MRI. The tumor is within 12 cm (4.7 in) of the anal margin, with at least one high-risk factor. A measurable lesion is needed.
- Biomarker or test result
- People with dMMR or MSI-H status cannot join.
Main reasons for not taking part
- dMMR or MSI-H status
- Unexplained myelosuppression (low blood cell production)
- Distant metastasis or inguinal lymph node metastasis
- Active or past autoimmune disease
- Uncontrolled heart symptoms or disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06850090, who can take part
Where in China
- Shandong Cancer Hospital and InstituteJinan, ChinaContact: Jinbo Yue, DoctorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shandong Cancer Hospital and Institute
- Trial code
- NCT06850090
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
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.
Inclusion: 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.
Exclusion: 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; 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.