Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:

Trametinib Combined With Everolimus and Lenvatinib in the Treatment of Recurrent/Refractory Advanced Solid Tumors: a Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803318
• Other study ID #: ZZ3TKI-011
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: January 1, 2027

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Zhenfeng Zhang, MD, PhD
• Phone: +862039195966
• Email: zhangzhf[@]gzhmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors.

Description:

The tumor diameter was measured and the efficacy was evaluated after treatment with Trametinib combined with Everolimus and Lenvatinib.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Recurrent/Refractory advanced solid tumors

• Age between 18 and 85 years

• Expected life expectancy is greater than three months

Exclusion Criteria:

• Benign tumor

• Life expectancy is less than three months

• Serious medical commodities

• others

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Solid Tumor, Adult

Intervention

Drug:
• Combination of three inhibitors Trametinib, Everolimus and Lenvatinib
Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment.		up to 36 months
Secondary	Assessing progress free survival		48 months
Secondary	Assessing overall survival	Assessing overall time to survival.	48 months