NCT06301386

Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients

The Combination of Everolimus and PD-1 in the Treatment of Locally Advanced and Advanced Colorectal Cancer That Cannot be R0 Resected

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about efficacy of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.

Detailed description

Everolimus is an oral protein kinase inhibitor of the mTOR (mammalian target of rapamycin) serine/threonine kinase signal transduction pathway. Studies have shown that immunotherapy combined with protein kinase inhibitor has initial efficacy in the treatment of colorectal cancer. Therefore, the objective of this study is to evaluate the efficacy and safety of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
DRUG	PD-1	200mg intravenously every 3 weeks (Q3W), was administered until the occurrence of unacceptable toxic effects, or disease progression, withdrawal of consent, or withdrawal as judged by the investigator.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

2 sites across 1 country: China