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An Exploratory Clinical Study Evaluating the Efficacy and Safety of Tunlametinib Combined With Fruquintinib in the Third-line Treatment of Advanced Colorectal Cancer Patients With RAS Mutations.

ConditionCRC, Colorectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiu Huang

About this trial

This study is a prospective, open-label, single-arm clinical study aimed at evaluating the efficacy and safety of Tunlametinib combined with Fruquintinib in the third-line treatment of advanced colorectal cancer patients with RAS mutations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Blood routine: Hemoglobin ≥80 g/L (no blood transfusion in the last 14 days); Absolute neutrophil count ≥1.5×10^9/L; Platelet count ≥90×10^9/L;

Liver function: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); if liver metastasis is present, ALT and AST ≤5×ULN, ALP ≤6×ULN; Total bilirubin ≤1.5×ULN; Albumin ≥30 g/L;

Kidney function: Serum creatinine ≤1.5×ULN or creatinine clearance calculated by the Cockcroft-Gault formula >60 mL/min;

Heart function: Echocardiography shows left ventricular ejection fraction (LVEF) ≥55%; ECG QTcF ≤480ms; Creatine kinase (CK) ≤1×ULN, troponin/sensitive troponin ≤1×ULN;

Disqualifiers

There are contraindications that influence investigators' choices in the use of therapeutic drugs (according to the latest drug instructions).

Previously received MEK inhibitors;

Within 4 weeks before the first use of the drug, underwent major surgery (excluding biopsies and minor outpatient surgeries, such as the placement of vascular access) or experienced serious trauma;

There is the presence of clinically symptomatic third space effusion (such as large pleural effusion or ascites) that cannot be controlled through drainage or other methods;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tunlametinib combined with Fruquintinib

    Drug

    Tunlametinib combined with Fruquintinib

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Tunlametinib combined with FruquintinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progress Free Survival

Time from treatment beginning until disease progression

Time frame
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks

Secondary outcomes

1

Objecitve response rate

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Time frame
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
2

Disease control rate

Proportion of patients who achieved a complete response, a partial response, or stable diseas

Time frame
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
3

Duration of Response

the time from the initial assessment of CR or PR for subjects with the best tumor efficacy to disease progression or death from any cause.

Time frame
Through study completion, an average of 3 weeks
4

Overall Survival

Time from treatment beginning until death from any cause

Time frame
From date of treatment beginning until the date of death from any cause, through study completion, an average of 3 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liu Huang

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: