Actively Recruiting
A Single-center, Prospective Study of Surufatinib Combined with Gemcitabine and Nab-paclitaxel or Gemcitabine and Nab-paclitaxel Alone for First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
Led by Fudan University · Updated on 2025-07-30
65
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of surufatinib combined with gemcitabine and nab-paclitaxel chemotherapy compared to gemcitabine and nab-paclitaxel alone in treating patients with locally advanced or metastatic pancreatic cancer. This phase 2, single-center, prospective study includes patients who have previously received two cycles of AG chemotherapy without disease progression. The goal is to assess how these treatments affect disease progression and patient survival. Participants are divided into two groups: one receives surufatinib orally every day along with gemcitabine and nab-paclitaxel given intravenously on days 1 and 8 every three weeks, while the other group receives gemcitabine and nab-paclitaxel alone on the same schedule. Treatment continues until disease progression, unacceptable side effects, death, or withdrawal. Dosage adjustments are permitted based on protocol guidelines. Imaging scans are performed every six weeks to monitor tumor status. During the study, patients undergo regular evaluations including tumor imaging using RECIST 1.1 criteria, laboratory tests, vital sign checks, and electrocardiograms to monitor safety and treatment response. Researchers measure progression-free survival as the primary outcome, along with tumor response rates, overall survival, and disease control rates. The study continues until disease progression or death, with safety observed throughout. Participation duration varies based on individual treatment response and tolerance.
CONDITIONS
Brief Title
A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With AG or AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent with good compliance and follow-up
- Confirmed unresectable, locally advanced or metastatic pancreatic cancer by pathology or cytology
- Aged 18 to 75 years, any gender
- ECOG performance status 0-1 with expected survival of at least 12 weeks
- Received 2 cycles of first-line AG chemotherapy with response of complete response, partial response, or stable disease (excluding increased stable disease)
- Postoperative distant metastasis patients with adjuvant chemotherapy completed and recurrence after 6 months allowed
- At least one measurable lesion by MRI or CT as per RECIST 1.1 criteria
- No serious diseases of heart, lung, brain, or other organs
- Normal major organ and bone marrow function as specified (including blood counts, liver, kidney, cardiac function)
- Fertile patients agree to use effective contraception during study and 6 months after
You will not qualify if you...
- Participation in other antitumor drug trials within 4 weeks before enrollment
- Prior treatment with VEGFR inhibitors or immune checkpoint inhibitors
- Presence of BRCA1/2 germline mutation
- Obstructive jaundice not responsive to treatment
- Other malignancies within past 5 years except certain skin or cervical cancers
- Brain metastases present or history thereof
- Liver metastases covering 70% or more of liver volume
- Recent surgery or invasive procedure within 4 weeks with unhealed incision
- Uncontrolled pleural, pericardial effusion or ascites requiring drainage
- Recent local antitumor therapy within 4 weeks
- Significant electrolyte abnormalities
- Uncontrolled hypertension above specified limits
- Significant proteinuria
- Tumor risk of invading vital vessels causing fatal bleeding
- Recent significant bleeding or bleeding disorders
- Significant cardiovascular disease or arrhythmias
- Active or uncontrolled severe infections
- Unresolved toxicities from prior cancer treatment above grade 2
- Pregnancy or breastfeeding
- Other medical or metabolic conditions judged unsuitable by investigator
- Known HIV infection or active liver disease including hepatitis
- Active or suspected autoimmune diseases
- Allergy or suspected allergy to study drugs
- Other factors affecting safety or study results such as substance abuse or mental illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 treatment cycles of 3 weeks each, continuing surufatinib and gemcitabine until disease progression or discontinuation
Participants receive either surufatinib combined with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. Treatment cycles occur every 3 weeks and continue until disease progression, intolerable toxicity, death, or other protocol-specified reasons for stopping.
Visits on days 1 and 8 of each 3-week treatment cycle
Trial Site Locations
Total: 1 location
1
Fudan University ShangHai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
J
Jin Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here