New drug cocktail targets tough stomach cancer in Last-Resort patients
NCT ID NCT05905887
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a combination of two drugs—rivoceranib and paclitaxel—in 48 adults with advanced gastrointestinal stromal tumors (GIST) that have a specific protein marker (high P-glycoprotein) and have stopped responding to three standard treatments. The goal is to see if the combo can control the disease. Participants take both drugs daily or weekly in 28-day cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rivoceranib and paclitaxel
- What this could lead to
- If successful, this combination could offer a new treatment option for people with a hard-to-treat form of GIST that has stopped responding to standard therapies.
- What could go wrong
- This is a small, early-phase trial (48 people) with no control group, so results may not apply broadly. The drugs can cause side effects like nerve damage, low blood counts, and high blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 20 years or older, at the time of acquisition of informed consent * Histologically confirmed metastatic and/or advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene * P-glycoprotin IHC score \> 3 (Tumor tissue with disease progression after regorafenib treatment) * Failed (progressed and/or intolerable) after prior treatments for GIST, including at least imatinib and sunitinib, regorafenib. * Eastern Cooperative Oncology Group (ECOG) performance status 0 \~ 2 * Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0 * At least one measurable lesion as defined by RECIST version 1.1. * Adequate bone marrow, hepatic, renal, and other organ functions Neutrophil \>1,500/mm3 Platelet \> 100,000/mm3 Hemoglobin \>8.0 g/dL Total bilirubin \< 1.5 x upper limit of normal (ULN) AST/ALT \< 2.5 x ULN Creatinine \<1.5 x ULN * Life expectancy \> 12 weeks * Washout period of previous TKIs or chemotherapy for more than 4 times the half life ((Imitinib and regorafenib need 1 week and sunitinib need 2 weeks.) * Provision of a signed written informed consent Exclusion Criteria: * Women of child-bearing potential who are pregnant or breast feeding * Women or men who are not willing to use effective contraception entering the study period or until at least 3 months after the last study drug administration. * If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary/peripheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia. * Uncontrolled infection * Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible) * Uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2 * Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator * The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleedig event. (required transfusion or endoscopic or surgical intervention) * Currently clinically significant (within 7 days prior to screening) treatment of anticoagulants or other thrombolytic agents. A maximum dose of 325 mg/day of aspirin is allowed * History of uncontrolled hypertension (blood pressure ≥140/90 mmHg and change in antihypertensive medication within 7 days prior to screening) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy. * History of clinically serious opearation, bone fracture or non-healing wounds within the last 3 weeks prior to screening * History of other significant cardiovascular diseases or vascular diseases, within the last 6 months prior to screening (e.g., hypertensive crisis, and hypertensive encephalopathy or transient ischemic attack or significant peripheral vascular diseases\] that, in the investigator's opinion, may pose a risk to the patient on VEGFR inhibitor therapy. * History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies * Known diagnosis of HIV infection (HIV testing is not mandatory). * History of another primary malignancy that is currently clinically significant or currently requires active intervention. * Patients with clinically suspected brain metastasis symptom, brain metastases as assessed by radiologic imaging * Alcohol or substance abuse disorder. * Known hypersensitivity to rivoceranib or any component of its formulation or history of severe hypersensitivity to including Cremophor R EL(polyoxyethylated castor oil) drug * Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 * Active bacterial infections
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center, University of Ulsan College of Medicine
RECRUITINGSeoul, Seoul, 138-736, South Korea
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Other studies related to the condition(s) this trial covers.
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- Study aims to pinpoint ideal imatinib dose for GIST patients
- New hope for stubborn GIST: experimental drug DCC-2618 enters safety testing
- New hope for rare stomach cancer: chemo drug shows promise in early trial