NCT03814447

The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer

Extracted Fields (from Registry)
Protocol IDNCT03814447
Registration Date2019-01-24
StatusUnknown Status
SponsorShanghai 6th People's Hospital
CountryChina
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2019-08-16
Last Patient Out2023-01-01
Publicationn
Gender %FEMALE
Mean Age18 Years - 75 Years
LLM Classifications (Side-by-Side)
Field GLM
glm-5.1
7517ms / 9239 tok
CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
6403ms / 10620 tok
OPENAI
gpt-4o
Thinking: o3
5203ms / 9079 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 outpatient
shaky reasoning
✓ Unanimous Initial: outpatient
outpatient inpatient → inpatient → outpatient
shaky reasoning
✓ Unanimous Initial: inpatient Requery: inpatient — CAR-T cell therapy involves intensive conditioning chemotherapy (cyclophosphamide and fludarabine) followed by cell infusion and monitoring for serious adverse events including cytokine release syndrome, which requires hospitalization and continuous medical supervision. Thinking: outpatient — The trial protocol does not explicitly state that patients are admitted or hospitalized during CAR-T cell therapy administration.
outpatient outpatient → outpatient → outpatient
shaky reasoning
✓ Unanimous Initial: outpatient Requery: outpatient — The intervention involves administering a dose of CAR-T cells without indication of hospitalization, consistent with outpatient clinical trial practices. Thinking: outpatient — The protocol does not state that participants are admitted for the intervention, so by default the CAR-T infusion and follow-up are assumed to be delivered to ambulatory patients.
OK
setting_place hospital hospital hospital OK
feasibility feasibility RCT feasibility RCT feasibility 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 consists of a single pharmacologic/biological treatment protocol where lymphodepletion chemotherapy (fludarabine and cyclophosphamide) is used merely as a preparatory regimen to support the primary CAR-T cell therapy.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — This is a single-modality cell therapy intervention where the preparative chemotherapy (fludarabine and cyclophosphamide) serves as standard conditioning for CAR-T cell infusion rather than representing separate therapeutic components.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention involves a single type of approach, CAR-T cell therapy, combined with preparatory chemotherapy, which does not qualify as multi-component from different categories.
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 yes yes yes OK
outcome_qol yes yes yes OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub immunotherapy immunotherapy immunotherapy OK
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