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

• Status: Not yet recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Trifluridine

Criteria

Inclusion Criteria:

• 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 70 years old

• Karnofsky performance score ≥ 70

• Distance from tumor lower margin to anal verge < 12 cm

Exclusion Criteria:

• 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