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Efficacy and Safety of Jianpi Yangxue Decoction to Recurrent Ovarian Cancer with Targeted Therapy: A Multicenter Randomized Controlled Trial

Multicenter clinical study and exploration of the mechanism of Jianpi Yangxue recipe in patients of recurrent ovarian cancer treated with targeted therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053368
Enrollment
Unknown
Registered
2021-11-20
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

Experimental group:Targeted Therapy + Jianpi Yangxue Decoction
Control Group:Targeted Therapy

Sponsors

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female, aged 18 to 65 years; 2. Clinically diagnosed platinum-sensitive recurrent ovarian or fallopian tube cancer or primary peritoneal cancer (recurrence time >= 6 months from the last chemotherapy); 3. In accordance with the 2018 Chinese Ovarian Cancer Diagnosis and Treatment Standards, receive PARP inhibitor maintenance therapy after chemotherapy; 4. Patients with TCM syndrome type: spleen deficiency and blood deficiency type: pale complexion, fatigue and fatigue, shortness of breath, poor appetite, nausea and vomiting, irregular stool, pale tongue, thin white or greasy coating, thin and weak pulse. 5. Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0 to 2; 6. Cardiac color ultrasound indicates that the cardiac ejection fraction is within the normal range; 7. Ability to swallow pills; 8. Patients with good organ function and meeting the following indicators and no contraindications to chemotherapy: (1) Hemoglobin >= 90g/L; (2) White blood cells >= 4.0 x 10^9/L; (3) Platelets >= 100 x 10^9/L; (4) Neutrophils >= 1.5 x 10^9/L; (5) Aspartate aminotransferase is not more than 3 times the upper limit of normal; (6) Alanine aminotransferase is not more than 3 times the upper limit of normal; (7) Bilirubin is not more than 1.5 times the upper limit of normal; (8) Serum creatinine value is not greater than 1.5 times the upper limit of normal.

Exclusion criteria

Exclusion criteria: 1. Combined with other malignant tumors or other malignant tumors in recent 5 years, except skin basal cell carcinoma or flat cell carcinoma and cervical carcinoma in situ which have been fully treated and controlled; 2. Serious diseases with non malignant tumors which will affect the patient's compliance or force the patient into a dangerous situation; 3. Accompanied by other anti-tumor treatments or participate in other clinical trials; 4. Pregnant or lactating women and those of childbearing age refuse to accept contraceptive measures; 5. Dementia, mental disorder or any mental illness that hinders the understanding of informed consent; 6. Severe liver dysfunction, child Pugh grade C, and or severe cardiac insufficiency, cardiac function grade III or above.

Design outcomes

Primary

MeasureTime frame
Progression free survival;Adverse Effect;

Secondary

MeasureTime frame
Quality of Life;

Countries

China

Contacts

Public ContactZhu Tao

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

kernor@163.com+86 13858065156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026