NCT06429904Active, not recruitingPhase 2
Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer
A Prospective, Single Arm Study of Nimotuzumab Combined With NALIRIFOX in the Treatment of Locally Advanced Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 28 May 2024
Brief summary (registry, in English)
This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 21 May 2024
- Start date
- 15 May 2024
- Primary completion date
- May 2027
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT06429904
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 31
- From 15 May 2024 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Refuse chemotherapy or surgery;
- Undergone major surgery within 30 days;
Other illness
- History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
- Known allergy to prescription or any component of the prescription used in this study;
- With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C)
Lab values
- Use of EGFR-mab or EGFR-TKI within 30 days;
Other
- Other reasons that are not suitable to participate in this study according to the researcher's judgment
Who the study is looking for
- Age 18-75 years old, gender unlimited;
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- Locally advanced pancreatic cancer, no evidence of distant metastasis as demonstrated by imaging;
- Receive nimotuzumab and NALIRIFOX for voluntary, and patients can tolerate NALIRIFOX by researcher's evaluation;
- No prior tumor systemic therapy.
- Measurable disease according to RECIST criteria v1.1;
- Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥100×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance \> 60 mL/min;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Postoperative survival was expected to be ≥3 months;
- Fertile subjects are willing to take contraceptive measures during the study period.
- Good compliance and signed informed consent voluntarily.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.