Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer

NCT ID: NCT02635971

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2022-12-31

Brief Summary

This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002).

Detailed Description

Primary Outcome Measures:

To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.

Secondary Outcome Measures:

To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.

Exploratory Outcome Measures:

To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.

Conditions

Carcinoma, Pancreatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAI chemotherapy

Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.

Group Type: EXPERIMENTAL

Transcatheter arterial infusion

Intervention Type: PROCEDURE

Gemcitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Chemotherapy

Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.

Group Type: ACTIVE_COMPARATOR

Intravenous chemotherapy

Intervention Type: PROCEDURE

Gemcitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Interventions

Transcatheter arterial infusion

Intervention Type: PROCEDURE

Intravenous chemotherapy

Intervention Type: PROCEDURE

Gemcitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically/cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma.
• Measurable disease by RECIST criteria must be present.
• Karnofsky Performance Status ≥ 70
• Patients with adequate organ functions reflected by the laboratory criteria below:

Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine < 2.0 mg/dL Bilirubin < 1.5 mg/dL SGPT < 2.5 x normal Alk Phos < 2.5 x normal

• Prior local therapy, e.g., radiation, is allowed provided that at least 4 weeks washout time is given.
• Patients with jaundice must have a biliary drainage decompression operation before recruitment.
• Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Subject with metastatic disease.
• Prior treatment with systemic chemotherapy.
• Known allergies to the gemcitabine, oxaliplatin or iodine contrast agent.
• Subject with Child-Pugh grade Class C hepatic impairment, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected，or other contraindication for transcatheter infusion.
• Untreated or uncontrolled deep vein thrombosis, arterial thrombosis of lower extremity, or aneurysm.
• Concurrent infection requiring intravenous antibiotics.
• Skin injury or infection of groin area, or other situation that not appropriate for femoral artery puncture.
• Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
• Known central nervous system involvement and leptomeningeal disease
• Subject with previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhiqiang Meng

Professor, MD, Ph D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiqiang Meng, MD, Ph D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yehua Shen, MD, Ph D

Role: CONTACT

yehuash25@163.com

86-21-64175590 ext. 83625

Facility Contacts

Yehua Shen, MD, Ph D

Role: primary

yehuash25@163.com

86-21-64175590 ext. 83625

References

Huang C, Cheng CS, Shen Y, Chen H, Lin J, Hua Y, Feng L, Wu C, Wang P, Chen Z, Meng Z. Digital subtraction angiography-guided pancreatic arterial infusion of GEMOX chemotherapy in advanced pancreatic adenocarcinoma: a phase II, open-label, randomized controlled trial comparing with intravenous chemotherapy. BMC Cancer. 2024 Aug 2;24(1):941. doi: 10.1186/s12885-024-12695-8.

Reference Type: DERIVED

PMID: 39095759 (View on PubMed)

Other Identifiers

TAI-2015

Identifier Type: -

Identifier Source: org_study_id