Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Prospective Clinical Study

NCT07495384 | Recruiting DMC

• 1 other identifier: 2024-1318
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Recurrent Ovarian Cancer; Platinum Resistance

Keywords

CapsuleX; cisplatin

Outcome Measures

Primary Outcomes (1)

• To evaluate the objective response rate (ORR) of CapsuleX combined with cisplatin in platinum-resistant recurrent ovarian cancer patients.

  Five years

Study Arms (1)

CapsuleX Combined with Cisplatin

EXPERIMENTAL

Drug: CapsuleX

Interventions

CapsuleX DRUG

CapsuleX Combined with Cisplatin

CapsuleX Combined with Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gynaecological cancers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Zhentong Wei Medic

CONTACT

15804300686; zhentongwei2009@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VICE PRESIDENT

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 27, 2026
• Study Start: January 17, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)