| Protocol ID | NCT03814447 |
| Registration Date | 2019-01-24 |
| Status | Unknown Status |
| Sponsor | Shanghai 6th People's Hospital |
| Country | China |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2019-08-16 |
| Last Patient Out | 2023-01-01 |
| Publication | n |
| Gender % | FEMALE |
| Mean Age | 18 Years - 75 Years |
NCT03814447
The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer
| 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 |