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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of CapsuleX and cisplatin for treating platinum-resistant recurrent ovarian cancer. This single-arm, open-label, prospective clinical trial aims to assess how well this combination works (measured by objective response rate) and its safety by monitoring adverse events in patients with this challenging form of ovarian cancer. The study is sponsored by The First Hospital of Jilin University. Participants will receive CapsuleX combined with cisplatin as the experimental treatment. The trial does not include a comparison group and is designed to observe the effects of this combination specifically in patients whose cancer has recurred and is resistant to platinum-based therapies. The treatment duration and dosing details are determined by the study protocol, focusing on this combination therapy. During the study, participants will undergo regular evaluations including tumor assessments according to RECIST 1.1 criteria to measure response, and safety monitoring for adverse events. The main outcome measured is the objective response rate over a five-year period. Participants will also provide tumor tissue samples when possible and complete follow-up procedures as required. The expected survival time for participants is at least six months, and organ function and overall health status will be closely monitored throughout the trial.
CONDITIONS
Brief 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 on the day of consent
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Platinum resistance as defined by progression 3 to 6 months after last platinum therapy (first-line) or within 6 months after multiple lines
- Progression or intolerance during or after most recent treatment
- Received 2-3 lines of systemic antitumor therapy with progression within 6 months after last platinum treatment
- At least one measurable lesion per RECIST 1.1, untreated locally or progressed after local treatment
- Expected survival of 6 months or more
- ECOG performance status 0 or 1
- Sufficient organ and marrow function within 7 days before randomization
- Willing to provide archived or fresh tumor tissue samples if available
- Able and willing to comply with study and follow-up procedures
You will not qualify if you...
- Primary platinum-refractory disease with no response during first-line platinum chemotherapy or progression within 3 months
- Active central nervous system metastasis, leptomeningeal metastasis, or carcinomatous meningitis (stable brain metastases allowed under criteria)
- Received investigational drugs within 28 days before randomization
- Recent antitumor therapy within 28 days, or Chinese herbal medicine with antitumor indication within 14 days
- Local palliative treatment within 14 days before randomization
- Major surgery within 28 days before randomization
- Recent or ongoing gastrointestinal abnormalities including obstruction, perforation, bleeding, or abscess
- Uncontrolled moderate to large pleural effusions, pericardial effusion, ascites, or cachexia
- Other malignant tumors within past 5 years except certain skin or in situ cancers
- Current or past interstitial pneumonia or pulmonary disease needing systemic glucocorticoids
- Uncontrolled comorbidities such as active infections (HBV, HCV, HIV, tuberculosis, syphilis), uncontrolled hypertension, severe arrhythmias, recent heart events, or treatable thromboembolic events
- Unresolved toxicity from previous antitumor therapy above CTCAE grade 1 (stable grade 2 allowed)
- History of allogeneic bone marrow or organ transplantation
- Previous allergic or hypersensitivity reactions to antibody drugs
- Any condition that may affect safety or treatment compliance including mental illness, alcoholism, or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive CapsuleX combined with cisplatin to treat platinum-resistant recurrent ovarian cancer.
Visits occur regularly during treatment as per protocol
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
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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