Transcatheter Arterial Infusion To Patients With Advanced Pancreatic Cancer

Study Overview

Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer

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.

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.

Pancreatic Cancer

DRUG: Gemcitabine
DRUG: Nab paclitaxel

PTCA199-9

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-12-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-19
First Submitted that Met QC Criteria 2023-12-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-21
First Posted (ACTUAL) 2024-01-09	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1 (venous injection), 8 (venous injection), and 15 (transcatheter arterial infusion) every 4 weeks.	DRUG: Gemcitabine 1000 mg per square meter DRUG: Nab paclitaxel 120 mg per square meter of body-surface area

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion

nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1 (venous injection), 8 (venous injection), and 15 (transcatheter arterial infusion) every 4 weeks.

DRUG: Gemcitabine

1000 mg per square meter

DRUG: Nab paclitaxel

120 mg per square meter of body-surface area

Primary Outcome Measures	Measure Description	Time Frame
Overall survival，OS	OS of subjects from recruiting to the time of death from any cause	At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcome Measures	Measure Description	Time Frame
progression-free survival, PFS	PFS of subjects from recruiting to the time of disease progression	At the end of Cycle 1 (each cycle is 28 days)
objective response rate (ORR),	CR + PR	At the end of Cycle 1 (each cycle is 28 days)
disease control rate (DCR)	CR + PR + SD	At the end of Cycle 1 (each cycle is 28 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ying Yang, MD

Phone Number: 86 64175590

Email: yangying@fudanpci.org

Study Contact Backup

Name: Guopei Luo, MD

Phone Number:

Email: luoguopei@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Aigner KR, Gailhofer S, Selak E, Aigner K. Intra-arterial infusion chemotherapy versus isolated upper abdominal perfusion for advanced pancreatic cancer: a retrospective cohort study on 454 patients. J Cancer Res Clin Oncol. 2019 Nov;145(11):2855-2862. doi: 10.1007/s00432-019-03019-6. Epub 2019 Sep 10.
Liu X, Yang X, Zhou G, Chen Y, Li C, Wang X. Gemcitabine-Based Regional Intra-Arterial Infusion Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma. Medicine (Baltimore). 2016 Mar;95(11):e3098. doi: 10.1097/MD.0000000000003098.
Endo S, Kawaguchi S, Terada S, Shirane N. Hepatic Arterial Infusion Chemotherapy for Liver Metastases Following Standard Chemotherapy for Pancreatic Cancer. Intern Med. 2021 Jan 15;60(2):223-229. doi: 10.2169/internalmedicine.5449-20. Epub 2020 Sep 19.
Qiu B, Zhang X, Tsauo J, Zhao H, Gong T, Li J, Li X. Transcatheter arterial infusion for pancreatic cancer: a 10-year National Cancer Center experience in 115 patients and literature review. Abdom Radiol (NY). 2019 Aug;44(8):2801-2808. doi: 10.1007/s00261-019-02022-2.

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