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De klinische studie NCT07495397 voor Epitheliale Eierstokkanker is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Single-arm, Prospective Clinical Trial of Efficacy and Safety of Daphnetin Capsules Combined With TC Regimen for Targeted Maintenance Therapy After Initial Treatment of Stage III-IV Epithelial Ovarian Cancer (RO/R1) 98
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De klinische studie NCT07495397 is een interventioneel studie bij Epitheliale Eierstokkanker met de status rekruterend. Het doel is om 98 deelnemers te includeren vanaf 1 november 2025. De studie wordt geleid door The First Hospital of Jilin University en de voltooiing is gepland op 1 juni 2028. Laatste update op ClinicalTrials.gov: 27 maart 2026.
Beknopte samenvatting
Imaging evaluation was performed every 3 months (± 7 days) from enrollment, and real-time examination was performed if new lesions were suspected.
The study was divided into two parts:
Part 1: Rexiacin capsules assist in the treatment phase of the TC regimen. Part 2: Rexiacin capsule combined with targeted drug maintenance therapy after the end of chemotherapy.
The overall research cycle is roughly divided into sc...
Toon meerOfficiële titel
Single-arm, Prospective Clinical Trial of Efficacy and Safety of Daphnetin Capsules Combined With TC Regimen for Targeted Maintenance Therapy After Initial Treatment of Stage III-IV Epithelial Ovarian Cancer (RO/R1)
Aandoeningen
Epitheliale EierstokkankerAndere studie-ID's
- 25K203-001
NCT-ID
Startdatum (Werkelijk)
2025-11-01
Laatste update geplaatst
2026-03-27
Verwachte einddatum
2028-06-01
Inschrijving (Geschat)
98
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelThe combination of Ruixiangsu capsules with the TC regimen for targeted maintenance therapy in epith | Daphne Extract Capsules The combination of Ruixiangsu capsules with the TC regimen for targeted maintenance therapy in epithelial ovarian cancer |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
PFS | Imaging Assessment | Every three months. |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
Inclusion Criteria:
- Patients with stage III-IV treatment-naïve ovarian cancer aged 18 to 75 years (including cut-off values) who have completed satisfactory tumor cytoreductive surgery (R0+R1);
- Voluntarily sign the informed consent form;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Expected survival ≥ 12 weeks as assessed by the investigator;
- Adequate organ and bone marrow reserve.
- Willing to provide previous archival or fresh tumor tissue samples (if there is no previous archived tumor tissue, and the investigator assesses that the patient has a high risk of re-retrieving the primary or metastatic part of the tumor tissue specimen is exempted);
- Able to understand the requirements of the trial, willing and able to comply with the trial and follow-up procedures.
Exclusion Criteria: Those who meet any of the following conditions cannot be admitted to this trial:
- With bleeding tendency PT≥15s or platelet count <90×109/L or plasma fibrinogen ≤ 1.6g/L;
- with pulmonary artery embolism, inferior vena cava thrombosis;
- Primary central nervous system tumors or symptomatic central nervous system metastases, meningeal metastases or previous history of epilepsy. Patients with asymptomatic clinical control or central nervous system metastases that are symptomatic but judged stable by the investigator can be included, but the following conditions must be met at the same time: a. 4 weeks from stable clinical symptoms before the first dose≥ b. No evidence of progression of central nervous system disease with enhanced cranial MRI within 4 weeks prior to the first dose; c. Antiepileptic drugs, prednisone dosage ≤10mg/day or equivalent dose of hormones have been discontinued ≥ 2 weeks before the first dose;
- Other active malignancy within 5 years prior to the first dose. Except for locally cured tumors (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ of the breast, etc.);
- The following cardiovascular disease occurred within 6 months prior to the first dose: symptomatic heart failure with New York Heart Association Class (NYHA) of grade 2 or higher, left ventricular ejection fraction (LVEF) <50%, unstable arrhythmia or unstable angina, myocardial infarction requiring treatment, pulmonary embolism, uncontrolled hypertension (This protocol is defined as post-treatment systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite optimal antihypertensive therapy , and the investigator assesses that it is clinically significant);
- Have any other disease, physical examination or laboratory test results that make the use of the study drug unsuitable according to the investigator's judgment;
- Patients with chronic oral vitamin K disease are combined
- Subjects with untreated or under treatment for tuberculosis, including but not limited to pulmonary tuberculosis; Those who have received standardized anti-tuberculosis treatment and have been confirmed to be cured by the investigator can be included;
- Serious infection within 4 weeks or active infection within 2 weeks before the first dose;
- Those with the following diseases: human immunodeficiency virus (HIV) infection; Active hepatitis B virus infection \[positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) test \>200 IU/ml or 103 copies/ml\]; Hepatitis C virus infected \[positive HCV antibody and viral ribonucleic acid (HCV-RNA) test results\]; Treponema pallidum antibody positive and RPR positive;
- Known hypersensitivity or delayed allergic reaction to any component of the study drug;
- Known history of psychotropic, drug abuse, alcohol or drug abuse that affects the test results; Estimated insufficient compliance of patients to participate in this clinical study or having other factors that are considered unsuitable for participation in this study in the opinion of the investigator.
Verantwoordelijke instantie
Songling Zhang, Hoofdonderzoeker, VICE PRESIDENT, The First Hospital of Jilin University
Centraal Contactpersoon
Contact: Zhentong Wei Medic, 15804300686, [email protected]
1 Studielocaties in 1 landen
Jilin
The First Hospital of Jilin University, Changchun, Jilin, 130000, China
Zhentong Wei Medic, Contact, 15804300686, [email protected]
Rekruterend