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)

Summary

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 screening period, treatment period, and follow-up period: Screening period: -7d\~0d, that is, after the signing of the informed consent form, the screening assessment must be completed within 7 days; Treatment period: 1 dosing cycle every 3 weeks; During chemotherapy, blood routine, liver and kidney function tests were performed every week, tumor marker monitoring and safety evaluation were performed every cycle, and imaging evaluations were performed every 3 months (± 7 days) to evaluate the efficacy. After the end of chemotherapy, the maintenance treatment period and follow-up stage will be conducted, and biochemical tests such as tumor markers, blood routine, liver and kidney function will be performed every 3 months (± 7 days), and imaging evaluation will be performed to evaluate the efficacy, and the patient's self-evaluation results will be evaluated (FOSI, EQ-5D-5L). Peripheral blood immune indicators: Peripheral blood TBNK+Treg lymphocyte subset typing and activated lymphocyte cytokines were performed every 6 months (± 7 days) to monitor the patient's immune status. Medication is administered until an event that meets the criteria for treatment termination occurs or the clinical trial is closed. Clinical tumor imaging evaluation was completed (the evaluation method was consistent before and after, enhanced CT or enhanced MRI was preferred). Investigational drug treatment should be continued until the occurrence of disease progression, or withdrawal due to intolerable toxicity, or receipt of new anti-tumor therapy, or withdrawal of informed consent and voluntary withdrawal for other reasons, or study termination, whichever occurs first. The termination time of the study is the last subject who has received the study drug for 1 year or all subjects are out of the group, whichever is achieved first. Follow-up period: If the investigator decides to end the subject's treatment with the study drug, then the treatment period will be considered the end of (End of Therapy, EOT). All subjects, including those who discontinue treatment for any reason (except for loss to follow-up, death, withdrawal of informed consent), will have an EOT visit scheduled within 7 days after the investigator decides to end the subject's treatment with study drug. The EOT visit should include vital signs, physical examination, laboratory tests, and clinical tumor imaging evaluation (first enhanced CT or enhanced MRI). Safety follow-up: Subjects are required to have a safety visit 30 days (+7 days) after the last dose. If the subject plans to receive a new anti-tumor treatment within 30 days after the last dose, a safety follow-up will be conducted before receiving the new anti-tumor therapy. Safety visits are required at the study center and should be performed to assess for AEs, concomitant medications, and concomitant treatments. Until adverse reactions related to the study drug disappear, or drop to Grade ≤1, or return to baseline levels, or stable or acceptable levels assessed by the investigator. Survival follow-up: After the safety follow-up, subjects will be followed up for survival once every 3 months (± 7 days), and will be followed up by telephone until death, loss to follow-up, withdrawal of informed consent, or termination of the study.

Eligibility

Inclusion Criteria:

* Inclusion 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);
  2. Voluntarily sign the informed consent form;
  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  4. Expected survival ≥ 12 weeks as assessed by the investigator;
  5. Adequate organ and bone marrow reserve.
  6. 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);
  7. Able to understand the requirements of the trial, willing and able to comply with the trial and follow-up procedures.

Exclusion Criteria:

* Exclusion Criteria: Those who meet any of the following conditions cannot be admitted to this trial:

  1. With bleeding tendency PT≥15s or platelet count \<90×109/L or plasma fibrinogen ≤ 1.6g/L;
  2. with pulmonary artery embolism, inferior vena cava thrombosis;
  3. 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;
  4. 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.);
  5. 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);
  6. 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;
  7. Patients with chronic oral vitamin K disease are combined
  8. 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;
  9. Serious infection within 4 weeks or active infection within 2 weeks before the first dose;
  10. 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;
  11. Known hypersensitivity or delayed allergic reaction to any component of the study drug;
  12. 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.

Conditions2

Interventions1

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