A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imat… (NCT04633122) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib
China108 participantsStarted 2020-11-25
Plain-language summary
the primary objective of this study is to assess the efficacy (progression-free survival,PFS) of DCC-2618 (ripretinib, ZL-2307) and sunitinib in patients with advanced gastrointestinal stromal tumors after treatment with imatinib. This study will enroll approximately 98 subjects in around 18 sites in China mainland, and all subjects will be receiving DCC-2618 or Sunitinib in equal chance as treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients ≥18 years of age.
* Histological diagnosis of advanced GIST and capability of providing tumor tissue sample (the interval between tumor tissue collection and signing of informed consent form should be less than 3 years). Otherwise, biopsy is required.
* Provide molecular test report with KIT/PDGFRA mutation status prior to randomization.
* Patients must have progressed on imatinib or have documented intolerance to imatinib. Subjects must have discontinued imatinib treatment 10 days prior to the first dose of the study drug. All prior imatinib treatments will be considered as first-line (such as imatinib adjuvant therapy and imatinib dose increase).
* ECOG PS of 0-2.
* Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening.
* Patients of reproductive potential must agree to follow the contraception requirements.
* At least 1 measurable lesion according to the "RECIST v1.1-GIST-specific Criteria" (non-nodal lesions must be ≥1.0 cm in the long axis or ≥ double the slide thickness in the long axis) ; obtaining radiographic image results within 28 days prior to the first dose of study drug.
* Good organ function and bone marrow reserve function, including:
* Neutrophil count ≥ 1,000/µL
* Hemoglobin ≥ 8 g/dL
* Platelet count ≥ 75,000/µL
* Total bilirubin ≤ 1.5 × the upper limit of normal (ULN)
* AST and ALT ≤ 3×ULN, and AST and ALT≤ 5×ULN in …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.