Clinical trial NCT05517239: Gemcitabine With Oxaliplatin (GEMOX) in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment
Official title: Phase II Study of Gemcitabine With Oxaliplatin in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma, Unresectable, Advanced
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression free survival
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: From enrollment to 30 days follow-up after the end of treatment
measure: Response rate
timeFrame: from enrollment to 1 year follow-up after the end of treatment
measure: Overall survival
timeFrame: From enrollment to 1 year follow-up after the end of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
name: Hye Jin Choi
role: PRINCIPAL_INVESTIGATOR
References: