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Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST

ConditionGastrointestinal Stromal Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

The goal of this prospective study is to learn whether there is a synergistic effect when radiotherapy is combined with ripretinib in the treatment of patients with unresectable advanced GIST. It will also learn about the safety of this regimen.The main questions it aim to answer is: Dose radiotherapy combined with ripretinib prolong the time to disease progression for patients with advanced GIST?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation and signed informed consent;

age: 18 to 75 years, Male or female

Patients with histologically confirmed GIST and Imaging evaluated as unresectable recurrent and metastatic disease or locally advanced.

ECOG Performance Score: 0-2

Disqualifiers

estimated life-expectancy less than 3 months.

Patients who have received previous radiotherapy to the proposed radiotherapy site, or the tumor has significant mobility, poor tolerance of radiotherapy in adjacent organs, and who are considered unsuitable for radiotherapy after MDT discussion

Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.

If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period

Trial design

Design model

Single group

Treatments tested in this trial

  • simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib

    Radiation

    A cumulative radiation dose of 50 to 70 Gy is administered in 25-30 fractions, 5 fractions per week, to the target lesion(s). ripretinib: oral 150mg QD

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Radiotherapy combined with ripretinib groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to disease progression of irradiated lesions

Time from start of radiotherapy to progression of irradiated lesions

Time frame
Approximately 12 months since the first subject enrolled

Secondary outcomes

1

Time to disease progression of any lesions

Time from start of radiotherapy to progression of any lesions

Time frame
Approximately 12 months since the first subject enrolled
2

Overall survival (OS)

the time from start of radiotherapy to all-cause death.

Time frame
Approximately 12 months since the first subject enrolled
3

Objective Response Rate(ORR) of irradiated lesions

the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR) based on mRECIST 1.1

Time frame
Approximately 12 months since the first subject enrolled

Other outcomes

Sponsors and contacts

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

First Affiliated Hospital of Chongqing Medical University

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Source ClinicalTrials.gov
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