NCT05965531RecruitingPhase 2
Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy
A Single-arm, Phase II Clinical Trial to Treat Locally Advanced, pMMR Rectal Cancer With Single-agent Trifluridine/Tipiracil Chemotherapy Plus Neoadjuvant Intensity-modulated Radiotherapy
Source: ClinicalTrials.gov · Last updated 29 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this Phase 2 trial is to evaluate a neoadjuvant treatment mode for locally advanced rectal cancer (LARC), consisting of radiotherapy and concurrent Trifluridine/Tipiracil (TAS-102). The main questions it aims to answer are: (i) whether TAS-102 is effective in treating LARC, when combined with radiotherapy; (ii) whether TAS-102 is safe in combination with radiotherapy. Participants will receive one cycle of TAS-102 chemotherapy and neoadjuvant radiotherapy based on intensity-modulated technique. Then the ones with a possibility of R0 resection will receive radical surgery followed by 6 cycles of adjuvant XELOX (capecitabine plus oxaliplatin) chemotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 14 Jul 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT05965531
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 65
- From 1 Jan 2024 to the primary completion date, 31 Dec 2028
- 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.
Prior treatment
- Prior history of rectal surgery, pelvic radiotherapy or chemotherapy
Other illness
- Multiple primary colorectal cancer
- Complete obstruction or perforation
- Uncontrolled tuberculosis, AIDS or mental diseases
- Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy or radiotherapy
- Prior history of other malignancies with 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma
Other
- Inguinal lymph node metastasis
- Pregnant or lactating women
- Other situations for which the investigators consider a patient inappropriate to participate
Who the study is looking for
- Pathologically diagnosed rectal adenocarcinoma via biopsy
- Pretreatment clinical TNM stage as T3-4N0M0 or T1-4N1-2M0 (UICC TNM staging classification, version 8)
- Tumor with proficient DNA mismatch repair confirmed by immunohistochemical analysis
- Age between 18 and 75 years old
- Karnofsky performance score ≥ 70
- Distance from tumor lower margin to anal verge \< 12 cm
Age in the registry: 18 years to 70 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 |
|---|---|---|---|
| Cancer Center, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.