NCT07090031

Perioperative Treatment With TAS-102 in Combination With Oxaliplatin for Locally Advanced Rectal Cancer

Perioperative Treatment With TAS-102 in Combination With Oxaliplatin for Locally Advanced Rectal Cancer: A Single-arm, One Center Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Qingdao Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

5-Fluorouracil (5-FU) based chemoradiotherapy is regarded a standard perioperative treatment in locally advanced rectal cancer, but the effective rate still low. We investigate oral TAS-102 plus oxaliplatin concurrent radiotherapy for stage II or III local advanced rectal cancer.

Conditions

• EFS
• pCR Rate

Interventions

Type	Name	Description
DRUG	TAS-102 in combination with oxaliplatin	Induction : TAS102 35mg/m2, twice a day for 5 days, on 1st, 3rd, 5th week; Oxliplatin 85mg/m2 on 1st and 2nd week; Rectal radiotherapy 50GY/25f in 5 weeks. 2 weeks no treatment. Consolidation: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 3 cycles. 4 weeks no treatment. Surgery Adjuvant chemotherapy: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 16 cycles.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: China