Recurrent Ovarian CancerNCT07495384
Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Prospective Clinical Study
A study testing CapsuleX in people with Recurrent Ovarian Cancer and Platinum Resistance, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer, Platinum Resistance
- What is being tested?
- CapsuleX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2025to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject can understand the informed consent, voluntarily participate and sign the informed consent;
- The subject is at least 18 years old on the day of signing the informed consent;
- Subjects with histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
- Platinum resistance is defined as: a. For subjects who have only received first-line platinum-based therapy, they must have received at least four cycles of platinum-based therapy and achieved disease response (CR or PR), with disease progression occurring between>3 months and ≤6 months after the last platinum-based treatment; b. For subjects who have received more than two lines of platinum-based therapy, disease progression must occur within <6 months after the last platinum-based treatment (at least two cycles).
- The subject must have had progression or intolerance during or after the most recent treatment;
- Previous 2-3 line systemic antitumor therapy, with progression within <6 months after the last platinum treatment and ≥3 months Note: a. New adjuvant and/or adjuvant therapy combined as line 1 treatment; b. Maintenance therapy (including monotherapy, targeted therapy, immunotherapy, and hormone therapy in the initial combination regimen) is considered part of the initial treatment (i.e., not counted separately); c. Lack of evidence of disease progression due to drug switching caused by toxicity is not considered a single treatment line (i.e., not counted separately); d. Insufficiently evaluated treatments without efficacy assessment (≤2 treatment cycles) are not considered a single treatment line (i.e., not counted separately); e. Endocrine therapy and targeted therapy are counted as separate lines unless used as maintenance therapy;
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- According to RECIST 1.1, the baseline should have at least 1 measurable lesion. Measurable lesions should not have been previously received Local treatment (such as radiotherapy), or evidence of disease progression after local treatment;
- Expected survival time is greater than or equal to 6 months;
- ECOG score 0 or 1;
- Sufficient organ/marrow function within 7 days prior to randomization, asdefined below;
- Willing to provide archived or fresh tumor tissue samples (if no archived tumor tissue is available and the investigator assesses that it would be risky for the subject to retrieve primary or metastatic tumor tissue samples);
- Able to understand the test requirements and willing and able to comply with the test and follow-up procedures.
Who cannot join
- Primary platinum-refractory is defined as disease that has not been relieved (CR) during first-line platinum-containing chemotherapy or within 3 months after the last dose Or PR) or imaging progression;
- History of active central nervous system metastasis, leptomeningeal metastasis or carcinomatous meningitis with stable evaluation by the investigator Excluding brain parenchyma metastases, stability is defined by the following criteria: no related symptoms and at least one recent imaging showing a stable state; or stable for more than 1 month without symptoms after treatment, and no need to use glucocorticoids or anticonvulsants for at least 2 weeks;
- Received any investigational drug within 28 days prior to randomization;
- Five half-lives (the shorter time) within 28 days prior to randomization of other antitumor therapy or antitumor drugs Equivalent but at least 14 days); Received Chinese herbal medicine with a clear anti-tumor indication within 14 days prior to randomization;
- Received local palliative treatment within 14 days prior to randomization;
- Had major surgery (such as abdominal or thoracic surgery; not including diagnostic surgery) within 28 days prior to randomization Small operations such as puncture or infusion device implantation or biliary stent implantation), or major surgery is expected to be required during the study treat;
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- There are obvious clinical manifestations of gastrointestinal abnormalities, including but not limited to: intestinal obstruction existed or existed within 3 months before administration Symptoms and signs of intestinal obstruction, but screening can be performed if surgery has been performed and the obstruction is completely relieved (if previously received Patients who have undergone gastrointestinal stent implantation and whose stents remain in place at the screening stage are not eligible for enrollment); within 3 months before dosing, there has been a gastrointestinal perforation, gastrostomy, or intra-abdominal abscess; within 3 months before dosing, there has been CTCAE grade ≥3 gastrointestinal bleeding, or within 1 month before randomization, there has been gastrointestinal bleeding (including melena, hematochezia, etc., if confirmed as hemorrhoidal bleeding or only positive occult blood in stool, they can be enrolled);
- Uncontrolled and recurrent (recurrent within 2 weeks of intervention) moderate to large pleural effusions such as the chest Subjects with water, pericardial effusion, ascites and cachexia;
- Other malignant tumors were combined within the previous 5 years, excluding curable squamous cell carcinoma of skin, basal cell carcinoma and non-basal infiltration Bladder cancer with lubrication, in situ prostate/cervical/breast cancer;
- Past or current interstitial pneumonia/pulmonary disease requiring systemic glucocorticoid therapy, or imaging during screening The examination could not rule out suspected interstitial pneumonia/pulmonary disease;
- The presence of uncontrolled comorbidities, including but not limited to:
- Active HBV or HCV infection. HBsAg (+), HBV-DNA <2500 copies/mL or 500 Enrollment is allowed at IU/mL; enrollment is allowed if HCV-Ab (+) and HCV-RNA test is negative;
- HIV infection;
- Known active tuberculosis;
- Active syphilis;
- There is an active or uncontrolled infection within 2 weeks prior to the randomization, and systemic antimicrobial therapy is required;
- Uncontrolled hypertension (systolic blood pressure ≥180mmHg, diastolic blood pressure> 100 mmHg) and symptomatic heart failure Full (NYHA II-IV), refractory hypokalemia, long QT syndrome, moderate to severe pulmonary hypertension;
- Severe arrhythmias of important medical significance, including but not limited to ventricular tachycardia, ventricular fibrillation, and apex torsion A history of transition tachycardia, complete left or right bundle branch block, second or third degree cardiac conduction block;
- Unstable angina or myocardial infarction within 6 months;
- New diagnosis of a treatable thromboembolic event within 6 months (control of stable lower extremity deep vein thrombosis or infusion Thrombosis subjects such as liquid ports are allowed to be included)
- The toxicity of previous anti-tumor therapy has not been restored to CTCAE≤1 grade (NCI-CTCAE v5.0); Note: Participants with stable grade CTCAE 2 toxicity related to prior anti-tumor therapy can be enrolled (defined as stable toxicity severity within 3 months before dosing, with no CTCAE grade greater than 2), such as neurotoxicity, hair loss, skin pigmentation, fatigue caused by chemotherapy, and endocrine toxicity from prior immunotherapy (e.g., thyroid dysfunction, diabetes, hyperglycemia, adrenal insufficiency);
- Previous history of allogeneic bone marrow or organ transplantation;
- History of previous allergic reactions to antibody drugs and hypersensitivity reactions;
- Other researchers believe that conditions that may affect the safety or compliance of treatment with the study drug, including but not limited to mental illness Class diseases, alcoholism or drug abuse, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Zhentong Wei Medic, 15804300686, zhentongwei2009@163.com
About this study
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
- Recurrent Ovarian Cancer, Platinum Resistance
- Being tested
- CapsuleX
- Keywords
- CapsuleX, cisplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsuleXDrug
CapsuleX Combined with Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| CapsuleX Combined with Cisplatin | Experimental | Not described Receives: Drug: CapsuleX |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the objective response rate (ORR) of CapsuleX combined with cisplatin in platinum-resistant recurrent ovarian cancer patients.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start17 Jan 2025
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songling Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495384
- Sponsor's protocol ID
- 2024-1318
- Status last verified
- Nov 2025
- First submitted
- 21 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07495384
- Acronym / sponsor ID
- 2024-1318
- Conditions
- Recurrent Ovarian Cancer, Platinum Resistance
- Keywords
- CapsuleX, cisplatin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CapsuleX Combined with Cisplatin | Experimental | Drug: CapsuleX |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject can understand the informed consent, voluntarily participate and sign the informed consent;
- The subject is at least 18 years old on the day of signing the informed consent;
- Subjects with histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
- Platinum resistance is defined as: a. For subjects who have only received first-line platinum-based therapy, they must have received at least four cycles of platinum-based therapy and achieved disease response (CR or PR), with disease progression occurring between>3 months and ≤6 months after the last platinum-based treatment; b. For subjects who have received more than two lines of platinum-based therapy, disease progression must occur within <6 months after the last platinum-based treatment (at least two cycles).
- The subject must have had progression or intolerance during or after the most recent treatment;
Key exclusion criteria (24 listed)
- Primary platinum-refractory is defined as disease that has not been relieved (CR) during first-line platinum-containing chemotherapy or within 3 months after the last dose Or PR) or imaging progression;
- History of active central nervous system metastasis, leptomeningeal metastasis or carcinomatous meningitis with stable evaluation by the investigator Excluding brain parenchyma metastases, stability is defined by the following criteria: no related symptoms and at least one recent imaging showing a stable state; or stable for more than 1 month without symptoms after treatment, and no need to use glucocorticoids or anticonvulsants for at least 2 weeks;
- Received any investigational drug within 28 days prior to randomization;
- Five half-lives (the shorter time) within 28 days prior to randomization of other antitumor therapy or antitumor drugs Equivalent but at least 14 days); Received Chinese herbal medicine with a clear anti-tumor indication within 14 days prior to randomization;
- Received local palliative treatment within 14 days prior to randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsuleXCapsuleX Combined with Cisplatin | Drug | CapsuleX Combined with Cisplatin |
Primary outcome
To evaluate the objective response rate (ORR) of CapsuleX combined with cisplatin in platinum-resistant recurrent ovarian cancer patients.
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CapsuleX in people with Recurrent Ovarian Cancer and Platinum Resistance, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhentong Wei Medic (15804300686, zhentongwei2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the objective response rate (ORR) of CapsuleX combined with cisplatin in platinum-resistant recurrent ovarian cancer patients. (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.