Actively Recruiting
Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Prospective Clinical Study
Led by The First Hospital of Jilin University · Updated on 2026-03-27
40
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial was designed as a single-arm, open-label, prospective clinical trial to evaluate the efficacy (ORR) and safety (AE incidence) of CapsuleX in combination with cisplatin for platinum-resistant recurrent ovarian cancer (PROC).
CONDITIONS
Official Title
Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Prospective Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- At least 18 years old at the time of consent
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Platinum resistance defined by specific disease progression timelines after platinum-based therapy
- Disease progression or intolerance during or after the most recent treatment
- Previous 2-3 lines of systemic antitumor therapy with progression within less than 6 months after last platinum treatment
- At least one measurable lesion per RECIST 1.1 without prior local treatment
- Expected survival time of at least 6 months
- ECOG performance status of 0 or 1
- Adequate organ and marrow function within 7 days before randomization
- Willing to provide archived or fresh tumor tissue samples
- Able to understand and comply with study and follow-up procedures
You will not qualify if you...
- Primary platinum-refractory disease without response or progression within 3 months after first-line platinum chemotherapy
- Active central nervous system metastases or leptomeningeal disease, except stable brain metastases
- Use of investigational drugs within 28 days before randomization
- Recent antitumor therapy or Chinese herbal medicine with anti-tumor effects within specified washout periods
- Local palliative treatment within 14 days before randomization
- Major surgery within 28 days before randomization or expected during study
- Recent gastrointestinal abnormalities including obstruction, perforation, abscess, or severe bleeding
- Uncontrolled moderate to large pleural effusions, pericardial effusion, ascites, or cachexia
- Other malignancies within 5 years except certain curable cancers
- Past or current interstitial lung disease needing systemic steroids or suspected on imaging
- Uncontrolled infections or comorbidities including active viral infections, severe heart conditions, and unstable thromboembolic events
- Unresolved toxicity from prior antitumor therapy above CTCAE grade 1
- History of allogeneic bone marrow or organ transplantation
- Previous allergic or hypersensitivity reactions to antibody drugs
- Any condition affecting safety or compliance including mental illness, alcoholism, or drug abuse
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
Z
Zhentong Wei Medic
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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