NCT06031376

Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC

Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC: A Retrospective Cohort Study Based on Propensity Score Matching

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However, it's still not clear that which therapy can bring better prognosis. Our study sought to investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the Hunan Cancer Hospital.

Detailed description

This is a retrospective cohort study conducted in Hunan Cancer Hospital. Patients (pts) with mCRC who had received at least the 2nd line treatment were eligible. Propensity score (PS) would be calculated to balance the baseline characteristics of two arms. Overall survival (OS) was set as the primary endpoint. From July 2019 to October 2022, 106 eligible pts in total were enrolled. According to the treatment received, 72 and 34 pts were respectively allocated into FP cohort and TB cohort.

Conditions

• Metastatic Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Fruquintinib	5mg once daily for 14 days on/7 days off, over a 21-day cycle
DRUG	PD-1 inhibitors	The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.
DRUG	Trifluridine/Tipiracil	TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days
DRUG	Bevacizumab	Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-10-31
• Completion: 2023-03-31
• First posted: 2023-09-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: China