Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    20
  • sponsor
    RenJi Hospital
Updated on 1 December 2021

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.

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.

Details
Condition gist, gastrointestinal stromal tumors, gastrointestinal stromal tumor
Treatment Ripretinib treatment
Clinical Study IdentifierNCT05132738
SponsorRenJi Hospital
Last Modified on1 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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
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