Status:
RECRUITING
Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy
Lead Sponsor:
Sun Yat-sen University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ma...
Detailed Description
The standard management recommended by the National Comprehensive Cancer Network for locally advanced rectal cancer (LARC) is neoadjuvant chemo-radiotherapy followed by surgery plus adjuvant chemother...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Inguinal lymph node metastasis
- 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
- Prior history of rectal surgery, pelvic radiotherapy or chemotherapy
- Pregnant or lactating women
- Other situations for which the investigators consider a patient inappropriate to participate
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05965531
Start Date
January 1 2024
End Date
December 31 2028
Last Update
April 29 2025
Active Locations (1)
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1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060