Actively Recruiting
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
Led by Fudan University · Updated on 2025-07-30
65
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment of patients with locally advanced or metastatic pancreatic cancer. Participants with previously received AG chemotherapy for 2 cycles with no disease progression will be enrolled: Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn; During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during the patient's treatment) or toxicity was intolerable or other criteria for termination of study treatment specified in the protocol were met, and the tumor treatment and survival status after disease progression were recorded. Safety observation indicators include: AEs, changes in laboratory values, vital signs, and changes in electrocardiogram.
CONDITIONS
Official 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 agree to participate and sign informed consent with good compliance and follow-up
- Have unresectable, locally advanced or metastatic pancreatic cancer confirmed by histopathology or cytology
- Aged between 18 and 75 years, male or female
- ECOG performance score of 0 to 1 and expected survival of at least 12 weeks
- Previously received 2 cycles of AG chemotherapy for locally advanced or metastatic pancreatic cancer with response of complete remission, partial remission, or stable disease (excluding stable disease with progression)
- For patients with postoperative distant metastasis, have received adjuvant chemotherapy and recurrence occurred more than 6 months after adjuvant therapy
- Have at least one measurable lesion per RECIST 1.1 criteria (MRI or CT measured diameter ≥10 mm; conventional CT diameter ≥20 mm)
- No serious organic diseases of heart, lung, brain, or other organs
- Normal major organ and bone marrow functions including: white blood cells ≥4.0 x 10^9/L, neutrophils ≥1.5 x 10^9/L, platelets ≥80 x 10^9/L, hemoglobin ≥90 g/L
- INR and APTT ≤1.5 times the upper limit of normal
- Liver function within specified limits (total bilirubin ≤1.5 x ULN, ALT/AST ≤3 x ULN, bilirubin ≤1.5 x ULN after drainage for obstructive jaundice)
- Renal function within specified limits (serum creatinine ≤1.5 x ULN, creatinine clearance ≥50 mL/min)
- Normal cardiac function with left ventricular ejection fraction ≥50% by echocardiography
- Fertile patients agree to use effective contraception during the study and for 6 months after last medication
You will not qualify if you...
- Participation in other antitumor drug clinical trials within 4 weeks prior to enrollment
- Prior treatment with VEGFR inhibitors or immune checkpoint inhibitors
- Presence of BRCA1/2 germline mutation
- Obstructive jaundice not improving as expected
- Other malignancies within past 5 years except certain skin cancers or carcinoma in situ of cervix
- Current or prior brain metastases
- Liver metastases involving 70% or more of liver volume
- Surgery or invasive treatment within 4 weeks prior to enrollment with unhealed incision
- Uncontrolled pleural, pericardial effusion or ascites requiring drainage
- Local antitumor therapy within 4 weeks prior to enrollment
- Clinically significant electrolyte abnormalities
- Medically uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Urinary protein ≥2+ and 24-hour protein >1.0 g
- Tumors at high risk of invading vital blood vessels causing fatal bleeding
- Significant bleeding history or tendency within 3 months prior to enrollment
- Significant cardiovascular disease including recent myocardial infarction or unstable angina
- Active or uncontrolled severe infection (CTCAE grade 2 or higher)
- Unresolved toxic reactions above CTCAE grade 2 from prior cancer therapy
- Pregnant or breastfeeding women
- Other medical or metabolic conditions judged unsuitable by investigator
- Known HIV infection or significant liver disease including active hepatitis B or C
- Active or suspected autoimmune disease
- Allergy or suspected allergy to study drugs
- Other factors affecting study results or patient safety such as alcoholism, drug abuse, serious lab abnormalities, or mental illness
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University ShangHai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
J
Jin Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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