Daphnetin plus TC chemotherapy and targeted maintenance after surgery for stage III–IV epithelial ovarian cancer

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)

This trial tests whether adding daphnetin capsules to standard paclitaxel‑carboplatin chemotherapy and then combining daphnetin with targeted maintenance can help people with stage III–IV epithelial ovarian cancer who had R0 or R1 surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Drugs / interventions: prednisone, chemotherapy
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT07495397 on ClinicalTrials.gov

What this trial studies

This is a single‑arm, prospective study enrolling treatment‑naïve patients with stage III–IV epithelial ovarian cancer who have undergone satisfactory cytoreductive surgery (R0 or R1). In Part 1, participants receive daphnetin capsules alongside standard paclitaxel‑carboplatin (TC) chemotherapy given every 3 weeks; in Part 2, daphnetin is continued together with a targeted maintenance drug after chemotherapy ends. During chemotherapy, blood counts and liver/kidney tests are performed weekly, tumor markers and safety are checked each cycle, and imaging is done every 3 months to monitor response. The study is conducted at The First Hospital of Jilin University and includes screening, treatment, and follow‑up phases with real‑time evaluation if new lesions are suspected.

Who should consider this trial

Good fit: Ideal candidates are treatment‑naïve adults aged 18–75 with stage III–IV epithelial ovarian cancer who completed R0/R1 cytoreductive surgery, have ECOG 0–1, adequate organ and marrow function, and can provide tumor tissue and attend regular follow‑up.

Not a fit: Patients unlikely to benefit include those with poor performance status (ECOG ≥2), prior systemic therapy for ovarian cancer, unresectable disease, significant organ dysfunction, or inability to comply with treatment and follow‑up.

Why it matters

Potential benefit: If successful, this approach could prolong the time before cancer recurrence and improve outcomes during maintenance therapy.

How similar studies have performed: Using daphnetin in ovarian cancer is largely novel with limited clinical data, whereas combining paclitaxel‑carboplatin with targeted maintenance (such as PARP inhibitors or anti‑angiogenics) has previously improved outcomes in similar populations.

Eligibility criteria

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.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Principal investigator: Zhang, Songling — The First Hospital of Jilin University
• Study coordinator: Zhentong Wei Medic

Conditions Epithelial Ovarian Cancer