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Trial Title:
Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer
NCT ID:
NCT06196788
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
1000 mg per square meter
Arm group label:
gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
120 mg per square meter of body-surface area
Arm group label:
gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion
Summary:
The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel
venous injection plus transcatheter arterial infusion to Patients with Advanced
Pancreatic Cancer.
Detailed description:
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%.
Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage.
Chemotherapy is one of the major treatments for advanced pancreatic cancer. The MPACT
trial has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the
first-line treatment to metastatic pancreatic cancer. However, the side-effects related
to gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness,
fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.
Regional intra-arterial infusion chemotherapy helps to deliver anticancer drugs into the
carcinoma tissue more selectively and is considered to be a potential alternative
treatment for advanced pancreatic adenocarcinoma with less systemic adverse effects.
Ohigashi et al first reported that intraarterial chemotherapy using 5-fluorouracil
improved the prognosis and quality of life in patients with advanced pancreatic
carcinoma.
The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel
venous injection plus transcatheter arterial infusion to patients with advanced
pancreatic cancer. Progression-free survival (PFS), objective response rate (ORR),
overall survival (OS) and disease control rate (DCR) are measured every three weeks.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Guopei Luo, MD
Phone:
86 21 64175590
Phone ext:
1307
Email:
luoguopei@fudanpci.org
Investigator:
Last name:
Guopei Luo, MD
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06196788
