| Protocol ID | NCT01245582 |
| Registration Date | 2010-11-22 |
| Status | Withdrawn |
| Sponsor | Sanofi |
| Country | – |
| Industry | industry |
| Blinding | unblinded |
| Center Type | – |
| Scope | – |
| First Patient In | 2011-07-01 |
| Last Patient Out | 2015-08-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 75 Years |
NCT01245582
A Randomized Phase III Study of Oxaliplatin (Eloxatin) and Capecitabine on Top of Sorafenib Versus Sorafenib Alone as First-line Palliative Treatment in Advanced Hepatocellular Carcinoma Patients
| Field |
GLM
glm-5.1 6450ms / 9237 tok |
CLAUDE
claude-sonnet-4-20250514 9441ms / 10573 tok |
OPENAI
gpt-4o 4209ms / 9071 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is a palliative oncology trial with an infusion delivered every 2 weeks; this treatment cycle typically takes place in an outpatient clinic or ambulatory day hospital setting rather than requiring inpatient hospital admission.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is an outpatient oncology treatment study where patients receive oral medications at home and periodic intravenous infusions at outpatient clinics, not requiring hospitalization.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The trial involves drug delivery through both oral and intravenous routes, with no specific mention of hospitalization or home care, suggesting an outpatient or clinic-based setting.
|
OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | yes | yes | yes | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is a single-modality pharmacologic treatment combining multiple chemotherapy drugs (oxaliplatin, capecitabine, and sorafenib) without components from different categories such as behavioral or educational interventions.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This is a pharmacologic intervention comparing a combination of three anticancer drugs (oxaliplatin, capecitabine, sorafenib) versus sorafenib alone, which represents a single intervention type despite using multiple medications.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial involves combining pharmacologic agents only (oxaliplatin, capecitabine, sorafenib), which are different drugs but all within the same pharmacologic category.
|
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 |