Gemcitabine With Oxaliplatin (GEMOX) in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment

NCT05517239 | Completed Phase 2 DMC

• 1 other identifier: 4-2014-0269
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety of gemcitabine and oxaliplatin regimen and to see its effects on sorafenib treatment failed hepatocellular carcinoma patients.

Conditions

Hepatocellular Carcinoma, Unresectable, Advanced

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

  1 year

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From enrollment to 30 days follow-up after the end of treatment

• Response rate

  from enrollment to 1 year follow-up after the end of treatment

• Overall survival

  From enrollment to 1 year follow-up after the end of treatment

Study Arms (1)

Gemcitabine, Oxaliplatin

EXPERIMENTAL

Gemcitabine 1,000 mg/m2 infusion for 30minutes and followed by oxaliplatin 100mg/m2 infusion for 2hours on day1. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.

Drug: Gemcitabine, Oxaliplatin

Interventions

Gemcitabine, Oxaliplatin DRUG

Gemcitabine 1,000 mg/m2 infusion for 30minutes and followed by oxaliplatin 100mg/m2 infusion for 2hours on day1. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.

Also known as: Gemzar, Eloxatin

Gemcitabine, Oxaliplatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who signed informed consent.
• Male or female ≥ 20 years of age.
• Diagnosis of advanced HCC according to the AASLD.
• Unresectable HCC
• Advanced disease defined as extrahepatic metastasis or locally advanced disease not amenable to surgical resection or other local-regional therapies including transhepatic arterial (chemo) embolization (TACE or TAE) and local ablative therapy
• Patient who progressed after prior local-regional therapy (local-regional therapy must be completed at least 4weeks prior to the baseline).
• Patients who progressed after or cannot tolerate sorafenib treatment. Patients who cannot receive sorafenib for other reason are also permitted.
• Documented radiological confirmation of disease progression during or after sorafenib treatment
• Intolerance to sorafenib is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation
• Patients must have a life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance state ≤ 2
• Measurable lesion according to the RECIST 1.1 criteria
• Child Pugh Class A or B7
• Patients must have adequate organ and marrow function:
• Absolute neutrophil count (ANC) ≥1.5X10\^9/L

You may not qualify if:

• Imaging findings for HCC corresponding to any of the following
• HCC with \>60% liver occupation
• Portal vein invasion at the main portal branch (Vp4)
• History of a secondary malignancy within 3 years
• \- in situ cervical cancer, adequately treated basal cell or superficial bladder cancer
• History of chemotherapy or radiotherapy within 4 weeks
• \- but, 2 weeks for sorafenib and radiotherapy site of bone lesion
• Patient who not recovered toxicity ≥ grade 2 related prior local-regional therapy or systemic therapy.
• Patients with any known severe allergy to Gemcitabine or platinum compound.
• Active gastro-Intestinal bleeding.
• Patients who are receiving any other chemotherapy or study treatments.
• Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
• Patients with active infections requiring an IV antibiotic.
• Neuropathy ≥ grade 2
• Patients with known interstitial lung disease or pulmonary fibrosis.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

gemcitabine-oxaliplatin regimen; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Hye Jin Choi

  Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 26, 2022
• Study Start: May 1, 2015
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2020
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)