Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer (NCT06361030) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer
China40 participantsStarted 2024-06-01
Plain-language summary
To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up;
✓. Aged 18-75 years old (including 18 and 75 years old)
✓. male or female
✓. Histologically or cytologically confirmed adenocarcinoma of the pancreas
✓. Unresectable pancreatic cancer according to radiographic criteria (CT or MRI scans) or exploration( NCCN guidelines were referred): (1)The portal and superior mesenteric vein could not be reconstructed safely due to tumor invasion, venous occlusion, or involvement of a large area of the superior mesenteric vein jejunal branch (2)If pancreatic head/uncinate tumor: tumor contacts superior mesenteric artery or celiac trunk artery \>180 degrees. If pancreatic body tail tumor: tumor contacts the superior mesenteric artery or celiac trunk artery\>180 degrees, and tumor contacts the celiac trunk artery and infiltrates the abdominal aorta.
✓. Without distant metastasis as defined by CT or MRI scan of the chest, abdomen and pelvis
✓. No prior systematic treatment for advanced pancreatic cancer
✓. At least one measurable lesion was required. (Response evaluation criteria in Solid Tumors, RECIST, version 1.1)
Exclusion criteria
✕. Participants had a second primary malignancy detected prior to the first dose of study treatment, or has other malignancies diagnosed within 5 years prior to the first dose of study treatment, with the exception of radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ;
What they're measuring
1
Surgical conversion rate
Timeframe: Time from the first treatment up to 24 weeks
Trial details
NCT IDNCT06361030
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
✕. With dysphagia or known malabsorption of drugs
✕. Have participated in any other drug clinical trial and received the corresponding trial drug within the previous 4 weeks. Or are participating in other clinical studies that may interfere with this study.
✕. Drug-uncontrolled hypertension;systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; History of hypertensive crisis or hypertensive encephalopathy.
✕. Patients with active gastric or duodenal ulcer, ulcerative colitis, intestinal obstruction, other gastrointestinal diseases, or active bleeding from unresectable tumors before enrollment, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator; Or have a history of bowel perforation or fistula and do not fully recover from surgery.
✕. Patients had a history of arterial or deep-vein thrombosis within 6 months before enrollment ,or had evidence or history of bleeding tendency, regardless of severity, within 2 months before enrollment.
✕. Stroke or transient ischemic attack occurred within 12 months before enrollment.