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Not Yet Recruiting NCT05641506

A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer

Conditions: Ovarian Cancer

Sex: Female
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 50
Sponsor: Sichuan Cancer Hospital and Research Institute

Location: China

Summary

This study is an open-label, single-Arm, phase II clinical trial of a Chinese Patent Medicine Yangzheng Xiaoji Capsule to improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Eligibility Criteria

Inclusion Criteria:Sign a written informed consent form before conducting any research-related procedures;Women aged 18 or above;Ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with Niraparib after evaluation by clinicians;Life expectancy > 3 months;Patients' ECOG physical condition score is 0-1, KPS score is ≥70;Patients received ≥ 3 cycles bevacizumab in combination within platinum-based chemotherapyGood organ function, including:Neutrophil count ≥ 1500/LPlatelet ≥ 100,000/LHemoglobin ≥10g/dLSerum creatinine ≤1.5 times the upper limit of normal value, or creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation)Total bilirubin ≤1.5 times the upper limit of normal value or direct bilirubin ≤1.0 times the upper limit of normal valueAST and ALT ≤2.5 times the upper limit of normal value, and liver metastasis must be ≤5 times the upper limit of normal value.7. No serious abnormalities of heart, brain, lung, liver and kidney function; 8. No serious mental illness; 9. Ability to comply with the plan; 10. the toxic and side effects of any previous chemotherapy have recovered to ≤CTCAE 1 grade or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤CTCAE 2 grade.Exclusion Criteria:People who are allergic to the ingredients in Yangzhengxiaoji CapsuleHave undergone major surgery within 3 weeks before the start of the study, or have not recovered any surgical effects after surgery, or have received chemotherapy.patients who are combined with other cancers;Patients with severe heart, liver, kidney and hematopoietic diseases; 5 Patients with poor compliance cannot take drugs according to regulations.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05641506). StuddyBuddy aggregates publicly available trial information.