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

NCT ID: NCT05517239

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2020-09-30

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.

Detailed Description

Patients who progressed after or cannot tolerate sorafenib treatment. Patients who cannot receive sorafenib for other reason are also permitted. Treatment is given in cycles, each cycle is 2 weeks long. Tumor measurements by CT and/or MRI will be repeated every 3 cycles. Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.

Conditions

Hepatocellular Carcinoma, Unresectable, Advanced

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine, Oxaliplatin

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.

Group Type: EXPERIMENTAL

Gemcitabine, Oxaliplatin

Intervention Type: 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.

Interventions

Gemcitabine, Oxaliplatin

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.

Intervention Type: DRUG

Other Intervention Names

Gemzar, Eloxatin

Eligibility Criteria

Inclusion Criteria

1. Patient who signed informed consent.

2. Male or female ≥ 20 years of age.

3. Diagnosis of advanced HCC according to the AASLD.

4. Unresectable HCC

5. 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

6. Patient who progressed after prior local-regional therapy (local-regional therapy must be completed at least 4weeks prior to the baseline).

7. 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

8. Patients must have a life expectancy of at least 12 weeks.

9. Eastern Cooperative Oncology Group (ECOG) performance state ≤ 2

10. Measurable lesion according to the RECIST 1.1 criteria

11. Child Pugh Class A or B7

12. Patients must have adequate organ and marrow function:

• Absolute neutrophil count (ANC) ≥1.5X10^9/L
• Platelets≥75X10^9/L
• Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) < 5 Upper Normal Limit(UNL)
• Total Bilirubin≤1.5 X UNL

13. Controlled brain metastasis is allowed(except brain metastasis to require treatment to control symptom-wash out of treatment for brain metastasis is not required.)

Exclusion Criteria

1. Imaging findings for HCC corresponding to any of the following

• HCC with >60% liver occupation
• Portal vein invasion at the main portal branch (Vp4)

2. History of a secondary malignancy within 3 years

• in situ cervical cancer, adequately treated basal cell or superficial bladder cancer

3. History of chemotherapy or radiotherapy within 4 weeks

• but, 2 weeks for sorafenib and radiotherapy site of bone lesion

4. Patient who not recovered toxicity ≥ grade 2 related prior local-regional therapy or systemic therapy.

5. Patients with any known severe allergy to Gemcitabine or platinum compound.

6. Active gastro-Intestinal bleeding.

7. Patients who are receiving any other chemotherapy or study treatments.

8. Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.

9. Patients with active infections requiring an IV antibiotic.

10. Neuropathy ≥ grade 2

11. Patients with known interstitial lung disease or pulmonary fibrosis.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hye Jin Choi

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2014-0269

Identifier Type: -

Identifier Source: org_study_id