Actively Recruiting
Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases : A Prospective, Single-Arm, Phase II Study
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-05-08
30
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with PCLM account for the majority of our department's pancreatic cancer cases and often have limited surgical options due to the aggressive nature of their tumors. For those with good performance status (ECOG PS 0-1), NCCN recommends gemcitabine + nab-paclitaxel (AG). Though nimotuzumab combined with gemcitabine improves survival, there remains scarce clinical data regarding its efficacy in conjunction with AG for treating PCLM. This study aims to evaluate the safety and efficacy of incorporating nimotuzumab with AG for PCLM.
CONDITIONS
Official Title
Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases : A Prospective, Single-Arm, Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Karnofsky Performance Status (KPS) of 60 points or higher
- Diagnosed pancreatic ductal epithelial adenocarcinoma with liver metastasis, not suitable for surgery or radiotherapy, and at least 6 months since last adjuvant chemotherapy
- At least one measurable lesion according to RECIST 1.1 criteria (longest diameter ≥10mm or lymph node shortest diameter ≥15mm)
- Expected survival time of 3 months or more
- Liver enzymes AST/ALT less than or equal to 5 times the upper limit of normal; total bilirubin less than or equal to 3 times the upper limit of normal
- Granulocyte count of at least 1.5 × 10^9/L; platelets at least 100 × 10^9/L; hemoglobin at least 90 g/L; creatinine clearance rate of 60 ml/min or more
- Voluntary participation with signed informed consent and good compliance
- Willingness for patients of childbearing age and their partners to use contraceptive measures
You will not qualify if you...
- Prior antitumor chemotherapy or molecular targeted therapy as palliative treatment before this study
- Target lesion has undergone radiotherapy without progression
- Participation in other therapeutic or intervention clinical trials within 4 weeks
- Major surgery within the last 4 weeks
- Presence of brain metastasis or leptomeningeal metastasis
- History of other malignancies except cured cervical carcinoma in situ, skin basal cell carcinoma, or other cancers cured for 5 years
- Symptomatic abdominal fluid requiring clinical treatment
- Serious illnesses such as uncontrolled congestive heart failure (NYHA III or IV), unstable angina, poorly controlled arrhythmias, high blood pressure (SBP >160 mmHg or DBP >100 mmHg), active infection, uncontrolled diabetes, mental illness affecting consent or adherence, HIV infection, or other serious conditions deemed unsuitable by researchers
- Known allergy to anti-EGFR antibody preparations
- Failure to conduct effectiveness or safety evaluations
- Use of other chemotherapy drugs or anti-cancer Chinese medicine during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300308
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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