Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy

Recruiting now · Phase 2

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT05965531

Run by

Sun Yat-sen University

People needed

65

Starts

2024-01-01

Expected to finish

2028-12-31

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Center, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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