Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib

  • STATUS
    Recruiting
  • End date
    Dec 27, 2025
  • participants needed
    304
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 27 January 2021

Summary

The study is being conducted to evaluate the efficacy and safety of famitinib in the treatment of advanced gastrointestinal stromal tumour patients after failure of imatinib compared to sunitinib.

Details
Condition gastrointestinal stromal tumor, gastrointestinal stromal tumors, gist
Treatment Famitinib capsules, Sunitinib Capsules
Clinical Study IdentifierNCT04409223
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The patients were enrolled voluntarily and signed informed consent, with good compliance and follow-up
Age 18 years (on the date of signing informed consent), for both men and women
Histologically confirmed metastatic or untreatable gastrointestinal stromal tumors have at least one measurable lesion that meets the criteria of RECIST v1.1. Lesions that have undergone radiotherapy must be confirmed by imaging to show progression after radiotherapy
Previous treatment with imatinib and eventual treatment failure (disease progression or toxicity intolerance during treatment)
The subjects were able to provide 10 ml blood samples and fresh or archived tumor tissue, or to receive biopsy at baseline for biomarker analysis
Note: if there is no archived tumor tissue sample, those at high risk of
receiving biopsy after assessment by the researcher, who can provide the
previous c-kit /PDGFRA test report, may also be selected for inclusion
\. Eastern Cooperative Oncology Group performance status of 1 or lower
\. Expected survival 12 weeks
\. Vital organs and body functions meet the following requirements (no blood
products or cell agents are allowed to be used within 14 days before the first
use)
Neutrophil absolute count 1.5109/L; Platelet 100109/L; Hemoglobin 90 g/L
Bilirubin 1.5ULN; ALT and AST 2.5ULN serum creatinine1.5ULN; Results of
urinary protein <2+; If urinary protein is 2+, 24-hour quantitative
determination of urinary protein should be conducted, and no more than 1g/24
hour is qualified. Serum calcium, potassium, magnesium and phosphorus are
within the normal range or have been corrected to the normal range before
randomization. International standardized ratio INR 1.5 and activated partial
thromboplastin time APTT1.5ULN; QTc 450 ms (male), 470 ms (female); Left
ventricular ejection fraction LVEF50%
\. Use of a medically approved contraceptive method (e.g., intrauterine
contraceptive device, contraceptive pill or condom) during the study period
and within 90 days after the end of the study period for female patients of
non-surgical sterilization or childbearing age; The serum HCG of female
patients of childbearing age without surgical sterilization must be negative
within 72 hours before randomization, and must be non-lactating to be
enrolled; For male patients whose partners are women of childbearing age
effective methods of contraception should be used during the study period and
within 90 days after the end of the study period

Exclusion Criteria

Previously received molecular targeted therapy for gastrointestinal stromal tumor except imatinib
The toxicity of previous imatinib or other treatments has not recovered or reached NCI CTC AE 5.0 1
For patients with clinical symptoms of ascites or pleural effusion, those requiring puncture drainage or those who had received thoracic or ascites drainage within 1 month before signing informed consent were excluded, those with only small amount of ascites or pleural effusion on imaging but no clinical symptoms are qualified
A second primary malignancy occurred within the last 5 years, except for adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix
Gastrointestinal stromal tumor with central nervous system metastasis
Inability to swallow, chronic diarrhea, intestinal obstruction, or factors that affect drug use and absorption
Bleeding grade 2 occurred in the first 4 weeks of randomization (NCI, CTC, AE 5.0)
Symptoms occurred within 12 months before randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or an arteriovenous embolism event (e.g., deep venous embolism of lower extremities, pulmonary embolism) within 6 months
There are clinical symptoms or diseases of the heart that are not well controlled, such as (1) heart failure above NYHA grade 2 (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention
Have hypertension, and cannot be well controlled by antihypertensive medication (systolic blood pressure 140mmhg or diastolic blood pressure 90mmhg, if the blood pressure was abnormal during the screening period, 2 consistent measurements must be done with an interval of more than 24h after medical correction); Previous hypertensive crisis or hypertensive encephalopathy
Drug uncontrollable thyroid dysfunction
Known acute or chronic active hepatitis, HBV virus titer > 500 IU, HCV RNA detection > ULN
History of immunodeficiency, including HIV positive, acquired or congenital immunodeficiency disorder, or a history of organ transplantation
Major surgery or radiotherapy within the first 4 weeks of randomization, or temporary palliative radiotherapy for pain relief within the first 1 week of randomization; Molecular-targeted therapy (including oral targeted drugs in other clinical trials) is less than 5 drug half-lives away form randomization date
Participated in clinical trials of other drugs in the first 4 weeks of randomization
Digestive tract perforation occurred 3 months before randomization
In the judgment of the investigator, a concomitant illness (severe diabetes, a clear history of neurological or mental disorders, e.g., epilepsy or dementia) that seriously endangers the patient's safety or prevents the patient from completing the study
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