Actively Recruiting
Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer
Led by Chinese PLA General Hospital · Updated on 2024-12-31
90
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS (nab-paclitaxel and S-1) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in unresectable advanced or metastatic pancreatic cancer.
CONDITIONS
Official Title
Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have fully understood this study and voluntarily signed the informed consent form
- Histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma
- Age between 18 and 75 years old (inclusive)
- No prior systemic therapy for advanced pancreatic carcinoma
- Eastern Cooperative Oncology Group performance status 0-1
- At least one measurable lesion with size meeting RECIST v1.1 criteria (longest diameter 6 10 mm by spiral CT or 6 20 mm by conventional CT)
- Expected survival of at least 3 months
- Adequate vital organ functions with specified blood counts and liver and kidney tests within allowed limits
- Women of childbearing potential must use effective contraceptive measures
- Good compliance and willingness to cooperate with follow-up
You will not qualify if you...
- Unable to comply with study protocol or procedures
- Previous treatment with VEGFR inhibitors or immune checkpoint inhibitors
- Participation in other drug clinical trials within 4 weeks prior to enrollment
- Receipt of transfusion therapy, blood products, or hematopoietic factors within 14 days prior to enrollment
- Brachytherapy within 60 days prior to enrollment
- Other systemic anti-tumor treatments within 4 weeks prior to enrollment
- Surgery or invasive treatment within 4 weeks prior to enrollment (except intravenous catheterization or paracentesis)
- Major surgery within 60 days prior to enrollment or unhealed surgical incision
- Local anti-tumor treatments such as hepatic arterial embolism or ablations within 4 weeks prior to enrollment
- Uncontrolled hypertension defined by blood pressure 6 140/90 mmHg
- Proteinuria 6 2+ or 24-hour protein urine 6 1.0 g
- Uncontrollable malignant ascites
- Clinically significant electrolyte abnormalities
- Liver metastases comprising half or more of total liver volume
- Significant cardiovascular disorders including recent myocardial infarction, severe angina, heart failure class > II, ventricular arrhythmia, or low ejection fraction
- Grade 3 or higher hemorrhage within 4 weeks prior to enrollment
- Recent hemorrhagic or thromboembolic events within specified time frames
- Elevated INR or APTT or current anticoagulant use
- Poorly controlled diabetes mellitus despite treatment
- Conditions affecting drug absorption or inability to take surufatinib orally
- Active or uncontrolled severe infection
- Known HIV infection
- Significant liver diseases including active viral hepatitis or cirrhosis
- Current or history of CNS metastasis
- Active gastrointestinal diseases that may cause bleeding or perforation
- Unresolved toxicities from prior anti-cancer treatments above specified grades
- Known allergy to study drugs or related drugs
- Pregnant or breastfeeding women
- Drug abuse or conditions affecting study participation or evaluation
- Other untreated or concomitant tumors except certain cured cancers
- Investigator judgment deeming patient inappropriate for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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