Actively Recruiting
Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-07-09
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
A
Akesobio
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, single-arm Phase II clinical study to evaluate the efficacy and safety of ivonescimab(AK112/SMT112) in combination with stereotactic body radiation therapy and chemotherapy in patients with pancreatic cancer
CONDITIONS
Official Title
Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and follow all study procedures
- Diagnosed with pancreatic ductal adenocarcinoma or adenosquamous carcinoma confirmed by tissue analysis
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease based on RECIST 1.1 criteria
- No previous radiotherapy or no overlap between previous and planned radiotherapy sites
- Adequate organ function
- Agree to use effective contraception during and for 120 days after study treatment if of reproductive potential
You will not qualify if you...
- Known active brain or meningeal metastases
- Untreated spinal compression fractures; treated fractures must be stable for at least 2 weeks before enrollment
- High risk of gastrointestinal or abdominal bleeding
- Uncontrolled cancer pain or unstable anesthetic painkiller dose
- Weight loss of 10% or more within 72 hours before study start
- Increase of 1 or more points in ECOG score within 72 hours before study start
- Unable to lie flat or remain still for 10-20 minutes during radiotherapy
- Prior use of agents targeting T cell costimulation or immune checkpoint pathways
- Known germline BRAC1/2 mutation
- Liver metastases occupying more than 50% of liver volume
- Immunodeficiency diagnosis or systemic steroid therapy within 2 years before study
- Recent chemotherapy, immunotherapy, or anti-tumor treatments within specified timeframes
- Major surgery within 30 days before study treatment
- Recent radical radiotherapy within 3 months; palliative radiotherapy allowed under conditions
- Use of systemic corticosteroids or immunosuppressants during first 14 days of study, except certain exceptions
- Difficult-to-correct albumin decline
- Live virus vaccine within 28 days before study treatment
- Known HIV/AIDS infection
- Active infection requiring systemic therapy
- Known active Hepatitis B or C infection
- Recent serious cardiac events within 6 months before study
- Other conditions or treatments that may interfere with participation or study results
- Pregnancy, breastfeeding, or planning pregnancy during study and 120 days after
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital of China
Wuhan, China
Actively Recruiting
Research Team
T
Tao Zhang
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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