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

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).

Eligibility

Inclusion criteria

1. The subject can understand the informed consent, voluntarily participate and sign the informed consent;
2. The subject is at least 18 years old on the day of signing the informed consent;
3. Subjects with histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
4. 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).
5. The subject must have had progression or intolerance during or after the most recent treatment;
6. 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;
7. 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;
8. Expected survival time is greater than or equal to 6 months;
9. ECOG score 0 or 1;
10. Sufficient organ/marrow function within 7 days prior to randomization, asdefined below;
11. 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);
12. Able to understand the test requirements and willing and able to comply with the test and follow-up procedures.

Exclusion criteria

1. 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;
2. 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;
3. Received any investigational drug within 28 days prior to randomization;
4. 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;
5. Received local palliative treatment within 14 days prior to randomization;
6. 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;
7. 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);
8. 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;
9. 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;
10. 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;
11. 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)
12. 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);
13. Previous history of allogeneic bone marrow or organ transplantation;
14. History of previous allergic reactions to antibody drugs and hypersensitivity reactions;
15. 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.

Conditions3

Interventions1

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