Phase II/III of Randomized Controlled Clinical Research on IRE Synchronous Chemotherapy for LAPC

NCT03673137 | Completed Phase 2 DMC

• 1 other identifier: Y2018-ZD-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have shown that irreversible electroporation (IRE) preoperative induction chemotherapy or adjuvant chemotherapy after IRE can reduce the local recurrence rate of locally advanced pancreatic cancer (LAPC) and benefit the survival of patients. According to the technical principle of electroporation therapy (EPT), when the cell membrane is electroporated, the resistance of cell membrane decreases instantaneously, which promotes the drug to enter tumor cells and significantly increases its cytotoxicity and killing effect on tumor tissue. The purpose of study is to evaluate the safety and effectiveness of simultaneous gemcitabine administration and IRE for treating LAPC. In order to provide new ideas for the treatment of LAPC.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Keywords

gemcitabine; pancreatic adenocarcinoma; Irreversible electroporation; overall survival time

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The time of patient from randomization to death caused by any cause

  3 years

Secondary Outcomes (2)

• Time to progression

  3 years

• Time to local recurrence

  3 years

Other Outcomes (2)

• Progression-free survival

  3 years

• Response rate

  3 years

Study Arms (2)

Synchronous treatment group

EXPERIMENTAL

Gemcitabine was administered over 30 minutes immediately following percutaneous irreversible electroporation. Gemcitabine was then given once weekly for 2 weeks, followed by a week of rest from treatment. Subsequent cycles consisted of once weekly infusions for 3 consecutive weeks out of every 4 weeks.Treatment continued until disease progression was detected by mRECIST or there was unacceptable toxicity.

Device: Irreversible electroporation; Drug: Gemcitabine

Traditional treatment group

ACTIVE COMPARATOR

The initial gemcitabine administration was on day 7 following IRE treatment. Once weekly infusions for 3 consecutive weeks out of every 4 weeks.Treatment continued until disease progression was detected by mRECIST or there was unacceptable toxicity.

Device: Irreversible electroporation; Drug: Gemcitabine

Interventions

Irreversible electroporation DEVICE

During the IRE process, we employed a CT scanner and an ultrasound system to guide percutaneous insertion of the electrode probes (one main electrode and one to three standard electrodes were used per treatment). The electrode number, electrode-insertion mode and intraoperative parameters were decided upon during pretreatment planning. The IRE parameters were visually simulated in the pulse generator and set up as follows: energy was applied at 1500 V/cm for 90 ms/pulse for a total of 7-9 pulses. After an initial testing pulse train was discharged to establish the best voltage value, the remaining 80 pulses were completed in 1-2 minutes. After ablation, we confirmed completion of IRE by measuring real-time resistance or current changes, in addition to intraoperative ultrasound and CT.

Synchronous treatment group; Traditional treatment group

Gemcitabine DRUG

Gemcitabine hydrochloride (Qilu pharmaceutical \[Hainan\] Co., Ltd. Haikou, China\] was administered by intravenous infusion at a dose of 1000 mg/m2.

Synchronous treatment group; Traditional treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed pancreatic cancer；
• Radiologic confirmation of AJCC stage III locally advanced pancreatic cancer；
• Histological or cytological confirmation of pancreatic adenocarcinoma;
• The maximum diameter of tumor is less than 5 cm；
• Biliary drainage in patients with biliary obstruction；
• PS 0-1
• Written informed consent

You may not qualify if:

• Resectable pancreatic adenocarcinoma;
• The tumor invaded the duodenum or stomach through mucosa；
• History of epilepsy;
• History of cardiac disease: congestive heart failure \> NYHA classification 2;
• cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker;
• Coronary artery disease and myocardial infarction occurred within 6 months before the screening；
• Uncontrolled hypertension. During screening, blood pressure should be controlled at less than 160/95 mmHg.
• Any implanted metal stent/device within the area of ablation that cannot be removed;
• Any implanted stimulation device;
• Uncontrolled infection (\>grade 2 according to NCI CTCAE V4.0);
• Pregnant or lactating women. Women suspected of pregnancy should be tested for pregnancy within 7 days before treatment.
• Allergy to contrast media;
• Compromised liver function: signs of portal hypertension; INR \>1.5 without use of anticoagulants; ascites;
• Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study；
• There was a history of chemotherapy within 1 months before screening；

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

Institutional Review Board of Guangzhou FUDA Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Interventions

Electroporation; Gemcitabine

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lizhi Niu, Doctor

  Guangzhou FUDA Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 17, 2018
• Study Start: September 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: July 30, 2021
• Last Updated: September 5, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)