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Clinical Trials in China / NCT05965531
Recruiting Phase 2

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

NCT05965531 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2024-01-01
Last updated
2025-04-29

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Trifluridine/Tipiracil →intensity-modulated radiotherapy

Trifluridine/Tipiracil: TAS-102 is given in a dose of 35 mg/m2, twice daily on the 1st to 5th and 8th to 12th days of the period of neoadjuvant radiotherapy.

intensity-modulated radiotherapy: intensity-modulated radiotherapy

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective response rate — One week after surgery
    The percentage of the patients complete R0 resection and attain a tumor regression grade of 1-4 (Mandard's 5-tier standard) in postsurgical pathologic examination

Trial sites (1)

FacilityCityRegionStatus
Cancer Center, Sun Yat-sen University Guangzhou Guangdong Recruiting

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Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC Starting soon
BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression Enrolling by invitation
Maintenance Immunotherapy With Deferred Salvage Radiotherapy After Response to Chemoimmunotherapy in Recurrent Nasopharyngeal Carcinoma Recruiting

Other trials for the same condition

A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI Recruiting
Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer Recruiting
A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer Active, not recruiting
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer Recruiting
Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05965531 on ClinicalTrials.gov ↗ ← All trials in China