CClinicalTrials.gg
RecruitingNCT04803318Updated Jun 25, 2024

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

A Phase 2 interventional study of Combination of three inhibitors Trametinib, Everolimus and Lenvatinib in Solid Tumor, Adult and Hepatocellular Carcinoma, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2021; still recruiting 5 years 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Solid Tumor, Adult
  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular Carcinoma;Lung Cancer
  • Trametinib
  • Everolimus
  • Lenvatinib
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 100 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 69 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Recurrent/Refractory advanced solid tumors
  • Age between 18 and 85 years
  • Expected life expectancy is greater than three months

Exclusion criteria

Exclusion Criteria:

  • Benign tumor
  • Life expectancy is less than three months
  • Serious medical commodities
  • others
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Combination treatment of 3 inhibitors

    Oral administration of 3 signaling pathways inhibitors: Mek inhibitor Trametinib, mTOR inhibitor Everolimus, and angiogenesis inhibitor Lenvatinib on refractory advanced solid tumors.

    Drug: Combination of three inhibitors Trametinib, Everolimus and Lenvatinib

Interventions

  • DrugCombination of three inhibitors Trametinib, Everolimus and Lenvatinib

    Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.

    Also known as: Combination of 3 signaling pathway inhibitors specific to MEK, mTOR, and angiogenesis.

06

What researchers measure

Primary outcomes

  1. Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment.

    Time frame: up to 36 months

Secondary outcomes

  1. Assessing progress free survival

    Time frame: 48 months

  2. Assessing overall survival

    Assessing overall time to survival.

    Time frame: 48 months

07

Study locations

1 of 1 sites recruiting
  • The Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510260, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04803318
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
Responsible party
Sponsor
First posted
Mar 17, 2021
Start date
Jan 1, 2021
Primary completion
Jan 1, 2029 (estimated)
Completion
Jan 1, 2037 (estimated)
Last update
Jun 25, 2024

Study contacts

Zhenfeng Zhang, MD, PhD
Contact
zhangzhf@gzhmu.edu.cn
+862039195966
Bingjia He, MD
Contact
zhangzhf@gzhmu.edu.cn
+862039195966
Zhenfeng Zhang, MD, PhD
principal investigator · Second Affiliated Hospital of Guangzhou Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion