Actively Recruiting
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2023-09-25
177
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, open-label， randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients with metastatic pancreatic cancer.
CONDITIONS
Official Title
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with ECOG performance status 2 or less and estimated survival time over 3 months
- Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
- At least one measurable lesion based on RECIST 1.1 criteria
- No previous systemic anti-cancer therapy
- Laboratory values meeting: WBC ≥ 3.0×10⁹/L; ANC ≥ 1.5×10⁹/L; Hemoglobin ≥ 90 g/L; Platelets ≥ 75×10⁹/L; Total bilirubin ≤ 1.5 times upper limit of normal; ALT and AST ≤ 2.5 times upper limit of normal or ≤ 5 times if liver metastases present; Serum creatinine ≤ 1 times upper limit or creatinine clearance ≥ 50 ml/min
- Left ventricular ejection fraction over 50% on Doppler ultrasound
- Use appropriate contraception if of childbearing potential
- Willing to sign informed consent and comply with study procedures
- Ability to follow the protocol and attend follow-up
You will not qualify if you...
- Previous systemic anti-cancer therapy
- Participation in other clinical trials within the last 4 weeks
- Surgically treatable or potentially treatable patients unless surgery was refused and evaluated
- Moderate ascites requiring drainage
- Central nervous system metastases or carcinomatous meningitis
- History of other primary malignancies except complete remission over 2 years or treated non-melanoma skin or carcinoma in situ with no recurrence
- Autoimmune disease or immune deficiency treated with immunosuppressive drugs
- Bleeding disorders
- Pregnant or breastfeeding women
- Drug abuse or psychological/social factors affecting consent or study conduct
- Known allergy to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel, or gemcitabine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
J
Juan Du
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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