Chiauranib in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (NCT06492915) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Chiauranib in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
China42 participantsStarted 2024-08-13
Plain-language summary
Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Understand and voluntarily sign the written informed consent form.
✓. Age 18-75 years on the day of signing the informed consent form, male or female.
✓. Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
✓. No prior systemic therapy for unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. Subjects who have received prior induction chemotherapy, concurrent radiotherapy, or adjuvant/neoadjuvant chemotherapy with curative intent, the interval of recurrence or metastasis must be at least 6 months after the last treatment.
✓. At least one measurable lesion according to RECIST v1.1. Previously irradiated lesions should not be selected as target lesions unless the previously irradiated lesion as the only measurable lesion and is unequivocally progressive based on imaging.
✓. ECOG score 0 or 1.
✓. Life expectancy≥3 months.
✓. Major organ functions meet the following criteria: Hematology: hemoglobin≥90g/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets≥100×10\^9/L(no haematopoietic growth factors or blood transfusions and other medications considered by the investigator to be corrective therapy, within 2 weeks before enrollment). Biochemistry: serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, AST/ALT≤2.5×ULN (≤5×ULN for patients with hepatic metastasis). Coagulation Function: INR \< 1.5×ULN.
Exclusion criteria
✕. Histological or cytological confirmed other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, pancreablastoma, etc.
What they're measuring
1
PFS
Timeframe: From the first dose to disease progression or end of study, an average of 1 year
✕. Previous received Aurora kinase inhibitors or systemic treatment of VEGF/VEGFR inhibitors such as bevacizumab, sorafenib, sunitinib, amlotinib, apatinib, and endostar.
✕. Previous radiation therapy, chemotherapy, immunotherapy, targeted therapy within 28 days prior to the first dose. Traditional Chinese medicine (except for Chinese herbal medicine) witn anti-malignancy effect judged by the investigator within 14 days prior to the first dose.
✕. Presence of active or untreated brain metastases, meningeal metastases, spinal cord compression, or molluscum contagiosum disease during the screening period. However, enrolment is permitted for subjects who meet the following requirements and have measurable lesion outside the CNS: asymptomatic after treatment and stable on imaging for at least 4 weeks prior to the first dose (e.g., no new or enlarging brain metastases) and have been off systemic glucocorticosteroids and anticonvulsant medications for at least 2 weeks prior to the first dose.
✕. Presence of clinically symptomatic pleural effusion, pericardial effusion or ascites requiring frequent drainage (≥1 time/month) during the screening period.
✕. Major surgery (craniotomy, thoracotomy, or laparotomy) or serious unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose. Needle biopsy or other minor surgery (except for intravenous infusion) within 7 days prior to the first dose.
✕. Significant arterial/venous thrombotic events within 6 months prior to first dose, such as deep vein thrombosis and pulmonary embolism. Superficial vein thrombosis without safety risk judged by the investigator is permitted.
✕. Cardiac dysfunction or clinically meaningful cardiovascular disease, including: (1)New York Heart Association (NYHA) grade II or higher congestive cardiac failure, unstable angina pectoris, and/or myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) \< 50% at screening. (2)Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy). (3)Clinically significant history of prolonged QTc interval, or QTcF interval \>470ms for females or \>450 ms for males during the screening period. (4)Coronary heart disease with symptoms requiring medication. (5)Documentation of hypertension treatment with≥3 antihypertensive medications simultaneously within 14 days before the first dose of medication or systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90 mmHg during the screening period (resting state, measured approximately every 5 minutes, averaged after three consecutive measurements, rounded to the nearest integer). (6)History of hypertensive crisis or hypertensive encephalopathy. (7)Other cardiovascular disease judged by the investigator to be unsuitable for enrolment.