NCT02426450

RFA Combined With Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) for Recurrent HCC:an Open Lable, Single-arm, Prospective Study

Extracted Fields (from Registry)
Protocol IDNCT02426450
Registration Date2015-04-27
StatusUnknown Status
SponsorSun Yat-sen University
CountryChina
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2015-04-01
Last Patient Out2017-04-01
Publicationn
Gender %ALL
Mean Age18 Years - 75 Years
LLM Classifications (Side-by-Side)
Field CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
5460ms / 11289 tok 		GLM
glm-5.1
6581ms / 9915 tok 		OPENAI
gpt-4o
Thinking: o3
4282ms / 9731 tok 		Review
rct_type N/A N/A N/A OK
cancer_status Cancer Cancer Cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient outpatient inpatient → outpatient
shaky reasoning
✓ Unanimous Initial: inpatient Requery: outpatient — The study involves radiofrequency ablation (RFA) which is a percutaneous procedure typically performed as an outpatient day procedure, followed by systemic chemotherapy infusions administered every 2 weeks in an outpatient setting.
 outpatient outpatient → outpatient
shaky reasoning
✓ Unanimous Initial: outpatient Requery: outpatient — RFA is typically a day procedure and FOLFOX4 chemotherapy with 22-hour infusions is administered in an outpatient or ambulatory care setting, with patients not requiring continuous hospitalization.
 outpatient outpatient → outpatient
shaky reasoning
✓ Unanimous Initial: outpatient Requery: outpatient — The intervention involves radiofrequency ablation and chemotherapy administered as infusions, which can be provided in outpatient settings without hospitalization.
 OK
setting_place hospital hospital hospital OK
feasibility N/A feasibility RCT → feasibility RCT → N/A
shaky reasoning
✓ Unanimous Initial: feasibility RCT Requery: feasibility RCT — This is a single-arm study with only 28 participants evaluating recurrence rate and safety outcomes, which suggests it's designed as a pilot/feasibility study to test the combination approach before a larger trial. Thinking: N/A — This is a single-arm, non-randomized prospective study, not an RCT.
 N/A N/A → N/A
shaky reasoning
✓ Unanimous Initial: N/A Requery: N/A — This is a single-arm, non-randomized interventional study rather than a randomized controlled trial.
 N/A feasibility RCT → N/A → N/A
shaky reasoning
✓ Unanimous Initial: feasibility RCT Requery: N/A — The study is an observational study as it is non-randomized and single-arm, focusing on evaluating efficacy and safety without a control group. Thinking: N/A — Single-arm phase II interventional study, not a randomized controlled trial.
 OK
intervention_pharmacologic yes yes yes OK
intervention_chemo_immuno_radio yes yes yes OK
intervention_complementary no no no OK
intervention_device yes yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The study uses RFA (radiofrequency ablation) which involves a physical medical device - specifically an RF 2000 system with needle electrodes and expandable electrode tines for ablation procedures.
 yes no → yes
shaky reasoning
✓ Unanimous Initial: no Requery: yes — The trial utilizes a radiofrequency ablation (RFA) system, which involves a physical needle electrode and generator hardware to treat hepatocellular carcinoma.
 yes yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The trial involves Radiofrequency ablation (RFA), which is a physical device/procedure used in the treatment.
 OK
intervention_psychological no no no OK
intervention_complex yes yes yes OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no no no OK
intervention_education no no no OK
intervention_digital no no no OK
intervention_other no no no OK
outcome_symptom no no no OK
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub chemotherapy chemotherapy chemotherapy OK
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