Infusion treatment for advanced pancreatic cancer
Gemcitabine and Nab-paclitaxel Venous Injection Plus Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer
This study is testing a new way to deliver chemotherapy directly to tumors in people with advanced pancreatic cancer to see if it helps them live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06196788 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining gemcitabine and nab-paclitaxel with transcatheter arterial infusion in patients with advanced pancreatic cancer. Given the high lethality and poor prognosis associated with this disease, the study aims to improve treatment outcomes by delivering chemotherapy directly to the tumor site, potentially reducing systemic side effects. Patients will be monitored for progression-free survival, overall survival, and other response metrics every three weeks. The approach is based on previous findings that localized chemotherapy can enhance patient quality of life and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with histologically confirmed advanced pancreatic adenocarcinoma who have not undergone major anti-cancer treatments.
Not a fit: Patients with non-adenocarcinoma pancreatic tumors or those who have received prior anti-tumor therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced pancreatic cancer.
How similar studies have performed: Previous studies have shown promise with localized chemotherapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Age ≥ 18 years and ≤ 80 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Histologically or cytologically confirmed advanced pancreas adenocarcinoma. * Primary pancreatic cancer without major anti-cancer treatments. * Locally advanced, or metastatic pancreatic cancer. * Presence of at least of one measurable lesion in agreement to RECIST criteria. * The expected survival ≥ 3 months. * Adequate organ performance based on laboratory blood tests. * Patients who are willing or able to comply with study procedures. Exclusion Criteria: * Pregnant or nursing women. * Patients who have received anti-tumor chemotherapy, radiotherapy, or other treatments. * The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. * Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. * Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results. * Cardiovascular and cerebrovascular accidents. * Allergic to study drugs. * Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ying Yang, MD
- Email: yangying@fudanpci.org
- Phone: 86 64175590
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.