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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma, Unresectable, Advanced
• Interventions: Drug: Gemcitabine, Oxaliplatin

• Registration Number: NCT05517239
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2019-09-30
• Study Completion: 2020-09-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Study First Posted: 2022-08-26
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine, Oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Progression free survival	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Response rate	from enrollment to 1 year follow-up after the end of treatment	Assessed by RECIST 1.1
Overall survival	From enrollment to 1 year follow-up after the end of treatment	Estimated by the Kaplan-Meier method
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	Overall safety profile verified as relevance of adverse events and laboratory abnormality based on CTCAE v4.0.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of