NCT05742620

Adjuvant Treatment of Digestive Tract Tumors

Follow-up and Registration Study of Anlotinib Combined With Adjuvant Chemotherapy in the Treatment of Locally Advanced Gastrointestinal Tumors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the 3-year Disease-free survival rate(DFSR) of patients with locally advanced gastric cancer and colorectal cancer treated with anlotinib combined with adjuvant chemotherapy.

Detailed description

Gastrointestinal tumor has a high incidence rate and mortality, which is one of the major diseases that seriously endanger the health of Chinese residents. Postoperative recurrence of colorectal cancer is the main cause of death in patients with advanced colorectal cancer. It is reported that the local recurrence rate after radical resection of colorectal cancer is 1% - 17%, and the 5-year survival rate after reoperation for recurrent and metastatic colorectal cancer is only 5% - 30%. In addition, the 5-year survival rate of locally advanced gastric cancer after operation is only 30-40%. The adjuvant treatment of locally advanced colorectal cancer and gastric cancer is still mainly radiotherapy and chemotherapy, and the research of anti-vascular targeted therapy combined with adjuvant chemotherapy for locally advanced colorectal cancer and gastric cancer is still under exploration. The research of antiangiogenic drugs combined with adjuvant chemotherapy in the treatment of locally advanced colorectal cancer and gastric cancer can fill this gap. Therefore, this study was designed to explore the efficacy and safety of antiangiogenic drugs combined with adjuvant chemotherapy in the treatment of locally advanced colorectal cancer and gastric cancer.

Conditions

• Adjuvant Treatment

Interventions

Type	Name	Description
DRUG	anlotinib+CAPEOX/SOX	Patients with colorectal cancer use the anlotinib+CAPEOX protocol, and patients with gastric cancer use the anlotinib+SOX protocol. Anlotinib: 12mg, administered once a day on day 1-14, taken about half an hour before breakfast (the time of daily administration should be the same as much as possible), delivered with warm water, repeated once every three weeks; CAPEOX: capecitabine 1000mg/m2 each time, oral, twice a day, 1-14 days; Oxaliplatin: 130mg/m2 iv drip d1. SOX: Tegio: 100mg/day, continuous medication for 2 weeks, stop for 1 week; Oxaliplatin: 130mg/m2 iv drip d1.

Timeline

• Start date: 2023-06-20
• Primary completion: 2026-07-20
• Completion: 2029-07-20
• First posted: 2023-02-24
• Last updated: 2023-02-24