Hepatocellular Carcinoma Clinical Trial
— PACOXOfficial title:
A Study of the Safety and Efficacy of Recombinant Human Arginase 1 (PEG-BCT-100) Combined With Capecitabine and Oxaliplatin in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
Verified date | July 2017 |
Source | Bio-Cancer Treatment International Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The propose of the study is to evaluate the maximum tolerated dose (MTD) of Oxaliplatin in combination with pegylated recombinant human arginase 1 (PEG-BCT-100) and Capecitabine and efficacy of this combination regimen (PACOX)in patients with advanced liver cancer.
Status | Completed |
Enrollment | 17 |
Est. completion date | October 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age>=18 years - Histologically or cytologically or clinically diagnosed advanced HCC not amenable or refractory or intolerance to surgery, or local-regional therapy, or targeted therapy. - Confirmed diagnosis of HCC according to the European Association for the Study of the Liver (EASL) criteria. - Child-Pugh class A or B - ECOG Performance State of 0 or 1 - Expected life expectancy of = 12 weeks - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening - Normal ECG - Subjects with at least one measurable target lesion at baseline in accordance with RECIST 1.1 Criteria. - Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. Exclusion Criteria: - Prior use of any systemic anti-cancer treatment for HCC other than targeted therapy, e.g. sorafenib. Systemic anti-cancer treatment for HCC includes chemotherapy, immunotherapy and hormonal therapy (except hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior to the start of trial treatment - Prior use of any approved or investigational targeted therapy for HCC, e.g. sorafenib, within two weeks prior to the start of trial treatment - Use of any local ablative treatment or TACE within 6 weeks prior to the start of trial treatment, and must have clear evidence of progressive disease after local treatment; - Radiotherapy within 3 weeks prior to the start of trial treatment. (Palliative radiotherapy will be allowed) - Major surgery within 4 weeks prior to the start of trial treatment - Use of biologic response modifiers, such as G-CSF, within 3 week prior to the start of trial treatment. - Concomitant treatment of rifampin or St John's Wort - Other investigational products within 4 weeks prior to the start of the trial treatment - Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry). - Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry. - Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within five days prior to the start of trial treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial. - History of cardiac disease: congestive heart failure > NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension - History of HIV infection - Known case of dihydropyrimidine dehydrogenase deficiency - Active clinically serious infections (> grade 2 NCI CTCAE version 4.0) - Patients with clinically significant gastrointestinal bleeding within 30 days prior to the start of trial treatment. - Patients with main portal vein tumor thrombosis - Patients with ascites uncontrolled by medication - Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) - Patients with previous liver transplantation - Patients undergoing renal dialysis - Known or suspected hypersensitivity to capecitabine, 5-fluorouracil, oxaliplatin or other platinum compounds, and any other agent given in association with this trial - Patients with significant peripheral sensory neuropathy with functional impairment - patients unable to swallow oral medications - Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong, Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Bio-Cancer Treatment International Limited | The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To evaluate the association between the biomarkers of ornithine transcarbamoylase (OTC) and argininosuccinate synthetase (ASS) in liver tissue and clinical response treated with PACOX regimen | The tumor tissue biomarkers, OTC and ASS, will be measured at baseline using standard immunohistochemical (IHC) staining method. IHC score will be produced for each tumor by summing up the intensity of the stain (0, 1, 2, 3) and the percentage of tumor with the corresponding intensity semi-quantitatively. | 1 year | |
Primary | The maximum tolerated dose (MTD) of Oxaliplatin (OX) in combination with PEG-BCT-100 (PA) and Capecitabine (C) in patients with locally advanced or metastatic hepatocellular carcinoma | There are 3 successive treatment cohorts in dose level of 85, 100 and 130 mg/m2 for Oxaliplatin. Subsequent treatment cohort is opened only after all patients in the previous cohort have completed the first 3 cycles of PACOX. At least 3 subjects will be treated at each cohort and observed for dose-limiting toxicity (DLT). If 1 of the 3 treated patients develops DLT at any dose level, 3 additional patients are to be entered at the same dose level. The dose of Oxaliplatin will be escalated if no DLT for the first 3 patients or 1 of the 6 treated patients develops a DLT. If 2 or more of the 3/6 patients at a given dose level experienced a DLT, dose escalation is stopped and the previous dose level is declared the MTD for the second part of the study. If the first 3 patients in Cohort 3 do not develop a DLT, an additional 3 patients will be enrolled in Cohort 3. If 1 or less than 1 patient in Cohort 3 has developed a DLT. the dose level is declared as the MTD. | 1 year | |
Primary | Time To Progression (TTP) | TTP will be measured from the date of first dose of the PACOX regimen until documentation of disease progression according to RECIST 1.1 Criteria. Death due to cause other than progression will be censored. Patient without an event will be censored at date last known progression-free. | 2 years | |
Secondary | Progression free survival (PFS) | PFS will be measured as the start of the PACOX regimen until documentation of disease progression according to RECIST 1.1 Criteria or death due to any cause. Patients without an event will be censored at date last known progression-free | 2 years | |
Secondary | Overall Survival (OS) | OS is defined as the time form the start of PACOX regimen until death due to any cause, censored at the last date known alive. | 2 years | |
Secondary | Response Rate (RR) | The overall disease response rate in accordance with RECIST 1.1 Criteria, which is defined as the percentage of patients who achieve either a complete response (CR) or partial response (PR) or stable disease (SD) | 2 years | |
Secondary | Serum alpha-fetoprotein (AFP) level | change in serum AFP level from baseline. | 2 years | |
Secondary | To evaluate the difference in disease response based on RECIST 1.1 Criteria and modified RECIST Criteria | 2 years | ||
Secondary | Safety events | Adverse Event (AE)/Serious AE evaluated by NCI CTCAE, version 4.0 | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04209491 -
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
|
||
Completed |
NCT03963206 -
Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)
|
Phase 4 | |
Completed |
NCT03268499 -
TACE Emulsion Versus Suspension
|
Phase 2 | |
Recruiting |
NCT05263830 -
Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
|
||
Recruiting |
NCT05044676 -
Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
|
||
Recruiting |
NCT05095519 -
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
|
Phase 2 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Completed |
NCT05068193 -
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03781934 -
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
|
Phase 1/Phase 2 | |
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT04401800 -
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
|
Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Active, not recruiting |
NCT04039607 -
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
|
Phase 3 | |
Terminated |
NCT03970616 -
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT03642561 -
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
|
Phase 2/Phase 3 | |
Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03222076 -
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
|
Phase 2 |