Gastrointestinal Stromal TumorsNCT05132738
Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy
A study testing Ripretinib treatment in people with Gastrointestinal Stromal Tumors, run by RenJi Hospital at 1 site in China.
Trial summary
To explore the efficacy and safety of preoperative treatment of potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumor (GIST) after failure of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Ripretinib treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be enrolled in the study:
- Patients voluntarily, and signed a written informed consent, good compliance with follow-up;
- 18 years ≤ age < 75 years, male or female;
- Histopathological examination confirmed the diagnosis of gastrointestinal stromal tumors, and immunohistochemical detection of CD117 and/or DOG-1 positive;
- According to the modified RECISTv1.1-GIST-specific (hereinafter referred to as"mRECIST") criteria, the subject has at least one measurable lesion (the long diameter of non-lymph node lesions is ≥ 1.0 cm or ≥ 2 times the scanning slice thickness); the lesions with definite progression after local treatment can also be considered as measurable lesions; the imaging results must be obtained within 21 days before the first dose;
- Potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumors who have failed imatinib treatment:
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- The number of evaluable lesions is ≤ 5 as judged by CT/MRI;
- The resection is considered to have significant risks by MDT assessment (meeting any of the following):
- The maximum diameter of a single lesion is ≥ 10 cm;
- Organ function damage surgery is required (gastrectomy, total gastrectomy, hepatectomy residual liver body ≤ 50% of the normal liver volume);
- Multiple organ resection surgery is required (partial gastrectomy combined with pancreatectomy/splenectomy, pancreaticoduodenectomy and abdominoperineal resection);
- The ECOG physical status score of patients is 0-2;
- Good organ function and bone marrow reserve, including:
- Neutrophil count ≥ 1.5 × 109/L
- Hemoglobin ≥ 90 g/L
- Platelets ≥ 100 × 109/L
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- AST and ALT ≤ 3 × ULN, and ≤ 5 × ULN in the presence of liver metastases
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula)
- Prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time ≤ 1.5 × ULN.
- QTc ≤ 450 ms (male), 470 (female): LVEF ≥ 50%
- Non-surgically sterilized or female patients of childbearing age need to use a medically recognized contraceptive (such as intrauterine device, contraceptives or condoms) during study treatment and within 90 days after the end of study treatment; non-surgically sterilized female patients of childbearing age need to confirm that they are not pregnant; and must be non-lactating; for male patients with partners of childbearing age, effective regimen contraception should be used during study treatment and within 90 days after the end of study treatment.
Who cannot join
- Patients with any of the following will not be enrolled in the study:
- Patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or Child-pugh class C or B whose symptoms are significantly difficult to correct, severe malnutrition, etc.;
- Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
- Patients with severe mental illness;
- The patient has participated in or is participating in other clinical studies , or is taking other TKI agents; has any clinically significant concurrent medical condition such as uncontrolled pulmonary disease, active infection, or any other condition that, in the opinion of the investigator, may affect patient compliance, interfere with interpretation of study results, or expose the patient to safety risks.
- Active viral infections such as human immunodeficiency virus, hepatitis B, and hepatitis C
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- Pregnant or lactating female patients or patients expecting to become pregnant during study treatment
- Known hypersensitivity to any component of the study drug.
- Gastrointestinal abnormalities, including but not limited to:
- Inability to swallow study drug
- Malabsorption syndrome
- Need for intravenous nutrition
- Any active bleeding, excluding hemorrhoids or gingival bleeding. Has any clinically significant concurrent medical condition, such as uncontrolled pulmonary disease, active infection, or any other condition that, in the opinion of the investigator, may affect patient compliance, interfere with interpretation of study results, or expose the patient to safety risks.
- The investigator considers that there are other factors that may affect the study results or cause the study to be terminated, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, with family or social factors that may affect the safety of patients.
- Other patients who may affect the conduct of the clinical study in the judgment of the investigator, may be unable to comply with the agreement or unable to cooperate, patients with study risks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Hui Cao, Professor, 13918141425, caohuishcn@hotmail.com
About this study
Official title: Ripretinib Used for Preoperative Treatment of Potentially Resectable Locally Advanced and Recurrent Metastatic GIST After Failure of Imatinib Therapy: An Exploratory Study
To explore the efficacy and safety of preoperative treatment of potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumor (GIST) after failure of treatment.
Read the detailed description
This study is a single-arm, single-center, exploratory study. A total of 20 patients were enrolled. The patient was orally administered with 150 mg of ripretinib daily. The study is expected to enroll the first patient in August 2021, last patient before March 30, 2023 and end the trial in November 2023. Subjects will receive up to 6 cycles of treatment before surgery, which will occur 1 week after the last dose of study drug. The subject requires discontinuation of study treatment or withdrawal from the study due to disease progression, intolerable toxicity, or Investigator's judgment.
The study will be divided into 3 periods: screening period, treatment period (visit period) and follow-up period. All subjects in the study were required to meet all inclusion criteria and exclusion criteria.
In this study, the screening period did not exceed 28 days, and eligible subjects who completed the screening tests and assessments entered the treatment period for study treatment and visits as specified in the protocol. Thereafter, participants entered the follow-up period. The safety follow-up period begins with 30 days of study treatment until 90 days after dosing, and subjects should receive telephone assessments every 30 days. After the safety follow-up period, subjects entered the survival follow-up period. Survival follow-up will be performed every 3 months until 1 year after treatment. Survival information and subsequent treatment information can be collected by effective means such as telephone follow-up. For subjects without radiographic evidence of disease progression, radiographic assessments should continue to be performed at the frequency of efficacy evaluations specified for this study.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Ripretinib treatment
- Keywords
- Gastrointestinal Stromal Tumors, Ripretinib, Imatinib
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripretinib treatmentDrug
Ripretinib: 4-week (28-day) cycle of oral administration of 150 mg q.d. For patients who completed up to 6 consecutive treatment cycles in a the clinical investigator decided whether to perform the operation or not, the specific time and other matters.
The above medications can be adjusted according to the adverse reactions of subjects according to the protocol at the investigator's discretion. Subjects will continue treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation of treatment as judged by the investigator, and the investigator will decide whether to perform early surgery or subsequent treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Ripretinib treatment group | Experimental | Not described Receives: Drug: Ripretinib treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
No Evidence of Disease Rate (NED Rate)
The primary study endpoint is to investigate the disease-free status rate of ripretinib for the preoperative treatment of potentially resectable locally advanced or recurrent metastatic GIST (NED Rate defined as patients who achieve R0 resection or complete response or macroscopic complete ablation of all known tumor lesions based on imaging assessment, with known tumor lesions assessed by CT or MRI at baseline and within 14 days after surgery, respectively).
Measured: baseline
No Evidence of Disease Rate (NED Rate)
The primary study endpoint is to investigate the disease-free status rate of ripretinib for the preoperative treatment of potentially resectable locally advanced or recurrent metastatic GIST (NED Rate defined as patients who achieve R0 resection or complete response or macroscopic complete ablation of all known tumor lesions based on imaging assessment, with known tumor lesions assessed by CT or MRI at baseline and within 14 days after surgery, respectively).
Measured: within 14 days after surgery
Secondary outcomes (3)
R0/R1 resection rate
R0 is the proportion of patients with no microscopic residual after resection/R1 is the proportion of patients with microscopic residual.
Measured: 1 days after surgery
Surgery rate
The proportion of patients who can undergo surgery.
Measured: up to 6 months
Objective response rate (ORR)
The proportion of patients who achieve complete response and partial response.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Aug 2021
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Cao, RenJi Hospital
- Investigators
- Hui Cao, Professor, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132738
- Sponsor's protocol ID
- Ripretinib for GIST
- Status last verified
- Nov 2021
- First submitted
- 15 Sep 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ripretinib Used for Preoperative Treatment of Potentially Resectable Locally Advanced and Recurrent Metastatic GIST After Failure of Imatinib Therapy: An Exploratory Study
- ClinicalTrials.gov ID
- NCT05132738
- Acronym / sponsor ID
- Ripretinib for GIST
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal Stromal Tumors, Ripretinib, Imatinib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy and safety of preoperative treatment of potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumor (GIST) after failure of treatment.
Detailed description
This study is a single-arm, single-center, exploratory study. A total of 20 patients were enrolled. The patient was orally administered with 150 mg of ripretinib daily. The study is expected to enroll the first patient in August 2021, last patient before March 30, 2023 and end the trial in November 2023. Subjects will receive up to 6 cycles of treatment before surgery, which will occur 1 week after the last dose of study drug. The subject requires discontinuation of study treatment or withdrawal from the study due to disease progression, intolerable toxicity, or Investigator's judgment.
The study will be divided into 3 periods: screening period, treatment period (visit period) and follow-up period. All subjects in the study were required to meet all inclusion criteria and exclusion criteria.
In this study, the screening period did not exceed 28 days, and eligible subjects who completed the screening tests and assessments entered the treatment period for study treatment and visits as specified in the protocol. Thereafter, participants entered the follow-up period. The safety follow-up period begins with 30 days of study treatment until 90 days after dosing, and subjects should receive telephone assessments every 30 days. After the safety follow-up period, subjects entered the survival follow-up period. Survival follow-up will be performed every 3 months until 1 year after treatment. Survival information and subsequent treatment information can be collected by effective means such as telephone follow-up. For subjects without radiographic evidence of disease progression, radiographic assessments should continue to be performed at the frequency of efficacy evaluations specified for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ripretinib treatment group | Experimental | Drug: Ripretinib treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients voluntarily, and signed a written informed consent, good compliance with follow-up;
- 18 years ≤ age < 75 years, male or female;
- Histopathological examination confirmed the diagnosis of gastrointestinal stromal tumors, and immunohistochemical detection of CD117 and/or DOG-1 positive;
- According to the modified RECISTv1.1-GIST-specific (hereinafter referred to as"mRECIST") criteria, the subject has at least one measurable lesion (the long diameter of non-lymph node lesions is ≥ 1.0 cm or ≥ 2 times the scanning slice thickness); the lesions with definite progression after local treatment can also be considered as measurable lesions; the imaging results must be obtained within 21 days before the first dose;
- Potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumors who have failed imatinib treatment:
Key exclusion criteria (15 listed)
- Patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or Child-pugh class C or B whose symptoms are significantly difficult to correct, severe malnutrition, etc.;
- Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
- Patients with severe mental illness;
- The patient has participated in or is participating in other clinical studies , or is taking other TKI agents; has any clinically significant concurrent medical condition such as uncontrolled pulmonary disease, active infection, or any other condition that, in the opinion of the investigator, may affect patient compliance, interfere with interpretation of study results, or expose the patient to safety risks.
- Active viral infections such as human immunodeficiency virus, hepatitis B, and hepatitis C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ripretinib treatmentRipretinib: 4-week (28-day) cycle of oral administration of 150 mg q.d. For patients who completed up to 6 consecutive treatment cycles in a the clinical investigator decided whether to perform the operation or not, the specific time and other matters. The above medications can be adjusted according to the adverse reactions of subjects according to the protocol at the investigator's discretion. Subjects will continue treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation of treatment as judged by the investigator, and the investigator will decide whether to perform early surgery or subsequent treatment regimen. | Drug | Ripretinib treatment group |
Primary outcome
No Evidence of Disease Rate (NED Rate)
Time frame: baseline
The primary study endpoint is to investigate the disease-free status rate of ripretinib for the preoperative treatment of potentially resectable locally advanced or recurrent metastatic GIST (NED Rate defined as patients who achieve R0 resection or complete response or macroscopic complete ablation of all known tumor lesions based on imaging assessment, with known tumor lesions assessed by CT or MRI at baseline and within 14 days after surgery, respectively).
No Evidence of Disease Rate (NED Rate)
Time frame: within 14 days after surgery
The primary study endpoint is to investigate the disease-free status rate of ripretinib for the preoperative treatment of potentially resectable locally advanced or recurrent metastatic GIST (NED Rate defined as patients who achieve R0 resection or complete response or macroscopic complete ablation of all known tumor lesions based on imaging assessment, with known tumor lesions assessed by CT or MRI at baseline and within 14 days after surgery, respectively).
3 secondary outcomes
R0/R1 resection rate
Time frame: 1 days after surgery
Surgery rate
Time frame: up to 6 months
Objective response rate (ORR)
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Cao, Professor study chair
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ripretinib treatment in people with Gastrointestinal Stromal Tumors, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Cao, Professor (13918141425, caohuishcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No Evidence of Disease Rate (NED Rate) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.