Actively Recruiting
A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer
Led by Hutchmed · Updated on 2026-05-28
502
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness and safety of a combination treatment using surufatinib with camrelizumab, nab-paclitaxel, and gemcitabine compared to nab-paclitaxel plus gemcitabine alone for patients with metastatic pancreatic cancer. This phase II/III multicenter trial focuses on patients with stage IV pancreatic cancer who have not received prior first-line systemic treatment for their metastatic disease. The study aims to assess how well these treatments work as initial therapies for this condition. The trial includes three treatment groups: one receiving surufatinib 200mg daily plus camrelizumab 200mg by intravenous drip every three weeks on day 1, nab-paclitaxel 125 mg/m2 intravenous drip on days 1 and 8, and gemcitabine 1000 mg/m2 intravenous drip on days 1 and 8; a second group receiving nab-paclitaxel and gemcitabine alone at the same doses and schedule; and a third group receiving surufatinib with nab-paclitaxel and gemcitabine. Treatments are given as first-line therapy for metastatic pancreatic cancer. Participants will be monitored for overall survival from the first dose until withdrawal or death, with follow-up up to about 20 months. Other key measurements include progression-free survival, response rates, duration of response, disease control, and cancer-related quality of life assessments during and after treatment. The study involves regular evaluations and safety monitoring to understand the impact of these therapies on patients' health and quality of life.
CONDITIONS
Brief Title
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process
- Age between 18 and 75 years old (inclusive)
- Pancreatic cancer confirmed by histology or cytology
- Stage IV metastatic pancreatic cancer
- No prior systemic first-line anti-tumor treatment for metastatic pancreatic cancer
- At least one measurable lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Expected survival time of at least 12 weeks
You will not qualify if you...
- Use of systemic non-specific immunomodulatory therapy within 2 weeks before the first dose
- Other malignancies within the past 5 years
- Major surgery within 4 weeks before the first dose
- Palliative radiotherapy within 1 week or radical radiotherapy within 4 weeks before the first dose
- Known allergy to surufatinib, camrelizumab, nab-paclitaxel, gemcitabine, or their components
- Use of strong inducers or inhibitors of cytochrome P450 3A within 2 weeks or 5 half-lives before the first dose
- Use of immunosuppressive drugs within 4 weeks before the first dose
- Clinically significant liver disease including active viral hepatitis or moderate to severe cirrhosis
- Uncontrolled hypertension despite medication
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 approximately 20 months or until disease progression, withdrawal of consent, or discontinuation
Participants receive assigned study drugs including surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine or nab-paclitaxel plus gemcitabine as first-line treatment for metastatic pancreatic cancer.
Regular visits for drug administration and assessments approximately every 3 weeks
Trial Site Locations
Total: 2 locations
1
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
2
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
P
Panfeng Tan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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