Combining TAS-102 chemotherapy with radiotherapy for advanced rectal cancer
A Single-arm, Phase II Clinical Trial to Treat Locally Advanced, pMMR Rectal Cancer With Single-agent Trifluridine/Tipiracil Chemotherapy Plus Neoadjuvant Intensity-modulated Radiotherapy
This study is testing if combining a specific chemotherapy drug with radiation can help people with advanced rectal cancer have better treatment results and fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05965531 on ClinicalTrials.gov |
What this trial studies
This Phase 2 trial aims to evaluate the effectiveness and safety of Trifluridine/Tipiracil (TAS-102) in combination with neoadjuvant radiotherapy for patients with locally advanced rectal cancer (LARC). Participants will receive one cycle of TAS-102 alongside intensity-modulated radiotherapy, followed by radical surgery for those eligible for R0 resection. After surgery, patients will undergo six cycles of adjuvant XELOX chemotherapy. The study seeks to improve treatment outcomes while minimizing the toxicities associated with traditional chemotherapy regimens.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with pathologically diagnosed rectal adenocarcinoma at specific clinical stages and good performance status.
Not a fit: Patients with inguinal lymph node metastasis, severe organ dysfunction, or prior malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and better-tolerated treatment option for patients with locally advanced rectal cancer.
How similar studies have performed: Previous studies have shown promising results with TAS-102 in metastatic colorectal cancer, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Guangzhou, Guangdong
- Cancer Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hui Chang, MD — Sun Yat-sen University
- Study coordinator: Hui Chang, MD
- Email: changhui@sysucc.org.cn
- Phone: +86-020-87343374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.