Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer

Phase 2

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: Gemcitabine; Drug: Nab paclitaxel

• Registration Number: NCT06196788
• Lead Sponsor: Fudan University

Brief 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.

Study Timeline

• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2023-12-26
• Study First Posted: 2024-01-09
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2026-03-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion	Nab paclitaxel	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.
gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Overall survival，OS	At the end of Cycle 1 (each cycle is 28 days)	OS of subjects from recruiting to the time of death from any cause

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China