Actively Recruiting
A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2024-09-04
120
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma.
CONDITIONS
Official Title
A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, male or female
- Diagnosis of locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma confirmed by tissue analysis
- No previous systemic treatment for locally advanced or metastatic pancreatic cancer
- At least one measurable tumor lesion according to standard criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate organ function
- Female participants must not be pregnant or breastfeeding and must have a negative pregnancy test within 7 days before starting treatment
- Both male and female participants of childbearing potential must agree to use highly effective contraception during the study and for 180 days after
- Voluntary participation with signed informed consent
You will not qualify if you...
- Use of other anticancer drugs such as chemotherapy, targeted therapy, immunotherapy, or biologics at the same time
- Known allergy to the study drug or its ingredients
- Recent heart problems within 6 months including myocardial infarction, severe or unstable angina, cardiac dysfunction (NYHA grade 2 or above), or significant heart rhythm problems needing treatment
- High risk of gastrointestinal or abdominal bleeding due to tumor invasion or blood vessel involvement
- Symptomatic brain metastases, leptomeningeal metastasis, or spinal cord compression from metastasis
- Other active cancers within the past 3 years, except certain treated skin or cervical cancers
- HIV infection or AIDS, active hepatitis, or co-infection with hepatitis B and C
- Need for systemic antibiotics for 7 days within 4 weeks before treatment or unexplained fever above 38.5°C before treatment
- Participation in other clinical trials
- History of substance abuse or significant neurological or mental disorders such as epilepsy or dementia
- Any other medical condition or risk that may affect study safety or results as judged by the investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
J
Jianming Xu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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