Actively Recruiting
A Study on Ivonescimab Plus Chemotherapy as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-05-31
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer.
CONDITIONS
Official Title
A Study on Ivonescimab Plus Chemotherapy as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years.
- Pancreatic cancer confirmed by tissue or cell examination.
- Borderline resectable pancreatic cancer.
- At least one measurable tumor lesion no larger than 6 cm.
- Tumor at least 0.5 cm away from gastrointestinal mucosa without clear invasion.
- No obvious lymph node metastasis.
- No previous anti-tumor treatment for pancreatic cancer.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate blood counts: ANC 6 1.5 x10^9/L, platelets 6 100 x10^9/L, hemoglobin 6 90 g/L, white blood cells 6 3.0 x10^9/L.
- Liver function tests with ALT and AST 4.5 times upper normal limit; total bilirubin 1.5 times upper normal limit.
- Kidney function with serum creatinine 1.5 times upper normal limit or creatinine clearance 60 ml/min.
- Use of medically accepted contraception during treatment and for 180 days after.
- Female participants must have a negative pregnancy test before first dose and must not be breastfeeding.
- Ability to understand the study and provide informed consent.
You will not qualify if you...
- Other cancers within the past 5 years, except cured in situ cancer or basal cell skin cancer.
- Major surgery within the past 28 days.
- Previous treatment with immunotherapy drugs like anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4.
- Presence of unresectable distant metastases.
- Active, uncontrolled infections needing systemic treatment.
- Known active HIV infection or untreated active hepatitis B or C infection.
- Uncontrolled serious systemic diseases such as unstable heart conditions.
- Severe gastrointestinal diseases like active bleeding, obstruction above Grade 1, or diarrhea above Grade 1.
- Contraindications to chemotherapy, radiotherapy, or surgery based on lab or clinical findings.
- Pregnant or breastfeeding women and women of childbearing potential who refuse contraception during the trial.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300308
Actively Recruiting
Research Team
L
Li Huikai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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