Actively Recruiting
Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy
Led by Sun Yat-sen University · Updated on 2025-04-29
65
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed rectal adenocarcinoma via biopsy
- Clinical stage T3-4N0M0 or T1-4N1-2M0 according to UICC TNM version 8
- Tumor with proficient DNA mismatch repair confirmed by immunohistochemical analysis
- Age between 18 and 75 years old
- Karnofsky performance score of 70 or higher
- Tumor lower margin located less than 12 cm from the anal verge
You will not qualify if you...
- Inguinal lymph node metastasis
- Multiple primary colorectal cancer
- Complete obstruction or perforation
- Uncontrolled tuberculosis, AIDS, or mental diseases
- Severe cardiac, renal, hepatic, or blood system dysfunctions unsuitable for chemotherapy or radiotherapy
- History of other malignancies within 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma
- Prior rectal surgery, pelvic radiotherapy, or chemotherapy
- Pregnant or lactating women
- Any other condition deemed inappropriate by the investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hui Chang, MD
CONTACT
Q
Qiao-xuan Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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