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

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.

Eligibility

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 75 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

Conditions2

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