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 range
18 Years – 75 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. Allergy to study medication or excipients
. 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.