Using Nimotuzumab with Chemotherapy for Pancreatic Cancer with Liver Metastases
Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases (PCLM): A Prospective, Single-Arm, Phase II Study
This study is testing if adding nimotuzumab to chemotherapy can help people with pancreatic cancer that has spread to the liver live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, nimotuzumab |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06404840 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of combining nimotuzumab with the AG chemotherapy regimen in patients with pancreatic cancer that has spread to the liver. It targets individuals with good performance status who are not candidates for surgery or radical radiotherapy. The trial aims to gather clinical data on this combination treatment to potentially improve survival outcomes for these patients. Participants will be monitored for their response to the treatment and any associated side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pancreatic ductal adenocarcinoma and liver metastases who have a good performance status.
Not a fit: Patients who have undergone recent chemotherapy or have severe liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates for patients with pancreatic cancer that has metastasized to the liver.
How similar studies have performed: While there is limited data on this specific combination, previous studies have shown that nimotuzumab can improve survival when used with gemcitabine, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) Age: 18-75 years old; 2) Physical strength KPS ≥ 60 points; 3) Pancreatic ductal epithelial adenocarcinoma with liver metastasis that has been diagnosed by pathological histology or cytology and is not suitable for radical radiotherapy or surgical treatment (should be at least 6 months away from the last adjuvant chemotherapy); 4) According to the RECIST 1.1 evaluation criteria, there should be at least one measurable and evaluable objective lesion (the longest diameter of the target lesion on spiral CT examination should be ≥ 10mm; if there is only lymph node metastasis, the shortest diameter should be ≥ 15mm); 5) Expected survival time ≥ 3 months; 6) Serum AST/ALT ≤ 5 times ULN; Total bilirubin ≤ 3 times ULN; Absolute count of granulocytes ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Creatinine clearance rate ≥ 60ml/min; 7) Voluntarily participate in this study, sign an informed consent form, and have good compliance; 8) Patients of childbearing age and their spouses are willing to take contraceptive measures. Exclusion Criteria: * 1\) Prior to this study, the following treatments were received: 1. Antitumor chemotherapy and molecular targeted therapy as a palliative measure 2. The target lesion has undergone radiotherapy without any progression 3. Within 4 weeks or currently participating in other therapeutic/intervention clinical trials 2) Received major surgery within 4 weeks; 3) Existing brain metastasis or leptomeningeal metastasis; 4) Have a history of other malignancies other than pancreatic cancer (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for 5 years); 5) Merge symptomatic abdominal fluid that requires clinical treatment; 6) Accompanied by other serious illnesses, including but not limited to: <!-- --> 1. Uncontrollable congestive heart failure (NYHA grade III or IV, see Appendix III), unstable angina, poorly controlled arrhythmias, uncontrolled moderate to high blood pressure (SBP\>160mmHg or DBP\>100mmHg) 2. Active infection 3. Difficult to control diabetes 4. Mental illnesses that affect informed consent and/or adherence to protocols 5. HIV infection 6. There are serious illnesses that other researchers believe are not suitable for participating in this study 7) Known to be allergic to anti EGFR antibody preparations. 1.3 Exclusion criteria * Failure to conduct effectiveness and/or safety evaluations; Serious violation of the protocol: While participating in this study, other chemotherapy drugs and/or modern Chinese medicine preparations with anti-cancer indications were used for treatment.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.