- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05517239
Gemcitabine With Oxaliplatin (GEMOX) in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment (PEACH)
Phase II Study of Gemcitabine With Oxaliplatin in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
-
Seoul, Korea, Republikken
- Yonsei University Health System, Severance Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
- Platelets≥75X10^9/L
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) < 5 Upper Normal Limit(UNL)
- Total Bilirubin≤1.5 X UNL
- 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:
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression free survival
Tidsramme: 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.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Tidsramme: 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.
|
From enrollment to 30 days follow-up after the end of treatment
|
Response rate
Tidsramme: from enrollment to 1 year follow-up after the end of treatment
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Assessed by RECIST 1.1
|
from enrollment to 1 year follow-up after the end of treatment
|
Overall survival
Tidsramme: From enrollment to 1 year follow-up after the end of treatment
|
Estimated by the Kaplan-Meier method
|
From enrollment to 1 year follow-up after the end of treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Hye Jin Choi, Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i fordøjelsessystemet
- Leversygdomme
- Neoplasmer i leveren
- Karcinom
- Carcinom, hepatocellulært
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gemcitabin
- Oxaliplatin
Andre undersøgelses-id-numre
- 4-2014-0269
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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