Actively Recruiting
A Phase II, Randomized, Double-blind, Placebo-Controlled Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2024-09-04
120
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of CEND-1 combined with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel with a placebo. This study focuses on patients with locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma who have not received prior systemic therapy. The goal is to find out if adding CEND-1 improves treatment outcomes. Participants will be randomly assigned to one of two groups. One group receives CEND-1 along with nab-paclitaxel and gemcitabine, while the other group receives a placebo with nab-paclitaxel and gemcitabine. Treatments are given intravenously on days 1, 8, and 15 of each 28-day cycle. This treatment schedule continues as first-line therapy. During the study, participants will be monitored for tumor response and survival outcomes over approximately 36 months. Researchers will assess objective response rate, overall survival, progression-free survival, and disease control rate. Safety will be tracked from the start of treatment until 30 days after the last dose. Participants will undergo regular evaluations including scans and health assessments throughout the study period.
CONDITIONS
Brief 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
- Confirmed locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma by histopathology or cytopathology
- No prior systemic therapy for locally advanced or metastatic pancreatic cancer
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate organ function
- Female participants must not be pregnant or breastfeeding and have a negative pregnancy test within 7 days before first dose
- Participants of childbearing potential must agree to use effective contraception during the study and for 180 days after
- Voluntary participation with signed informed consent
You will not qualify if you...
- Concurrent use of other anticancer drugs including chemotherapy, targeted therapy, immunotherapy, or biologics
- Known allergy to the investigational drug or its components
- Recent myocardial infarction, severe or unstable angina, grade 2 or higher cardiac dysfunction, or significant arrhythmia requiring treatment within 6 months
- High risk of gastrointestinal or abdominal bleeding due to tumor invasion
- Symptomatic central nervous system metastasis, leptomeningeal metastasis, or spinal cord compression from metastasis
- Other active malignant tumors within 3 years except certain skin, cervical, breast, or thyroid cancers
- HIV infection, AIDS, active hepatitis, or co-infection with hepatitis B and C
- Need for systemic antibiotics for 7 or more days within 4 weeks before first dose or unexplained fever above 38.5°C before first dose
- Participation in other clinical studies
- History of psychoactive drug, alcohol, or substance abuse; neurological or mental disorders including epilepsy or dementia
- Any added risks or factors interfering with study results as judged by the investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 28-day cycles
Participants receive CEND-1 or placebo combined with nab-paclitaxel and gemcitabine as first-line therapy for pancreatic ductal adenocarcinoma.
Visits on Day 1, 8, and 15 of each 28-day cycle
Duration - Up to 30 days after the last dose
Participants are monitored for safety and overall outcomes after completing treatment.
Approximately 1 follow-up visit
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here