BridgeMD
Tests treatment safety and results for Epithelial Ovarian Cancer
Official title 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)
ClinicalTrials.gov ID: NCT07495397
What this study is testing
What is Daphne Extract Capsules?
Daphne Extract Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for epithelial ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 1. Patients with stage III-IV treatment-naïve ovarian cancer aged 18 to 75 years (including cut-off values) who have completed satisfactory tumor...
- 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.
You likely can't join if
- 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...
- 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...
- The following cardiovascular disease occurred within 6 months prior to the first dose: symptomatic heart failure with New York Heart Association...
See the full eligibility criteria
- 1. 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...
- 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...
- 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...
- 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...
- 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
- people 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...
- 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)...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.