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Effect of Tumor Treating Fields (TTFields, 150 KHz) Concomitant with Chemotherapy As First Line Treatment of Unresectable Gastroesophageal Junction or Gastric Adenocarcinoma

NCT04281576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-11-14

No results posted yet for this study

Summary

The study is a prospective, single arm, phase II trial aimed to evaluate the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with XELOX for the treatment of unresectable, locally advanced or metastatic Gastroesophageal Junction (GEJ) or Gastric (GC) Adenocarcinoma who were previously untreated with systemic therapy. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Conditions

Interventions

DEVICE

NovoTTF-100L(P)

Patients receive continuous TTFields treatment using the NovoTTF-100L(P) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen. The treatment enables the patient to maintain regular daily routine.

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m\^2 intravenous infusion will be administered once every 3 weeks

DRUG

Capecitabine

Capecitabine 1000mg/m\^2 taken by mouth, twice daily on day 1-14, 3 weeks per cycle

DRUG

Trastuzumab

Trastuzumab (HER-2 positive patients only) intravenous infusion will be administered once every 3 weeks on Day 1 of each cycle. First dose is 8mg/kg, followed by 6 mg/kg.

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • NovoCure Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2024-06-07
Completion
2024-06-07

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04281576 on ClinicalTrials.gov