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A single-arm, open-label phase II clinical study of nab-paclitaxel combined with anlotinib in platinum-resistant recurrent ovarian cancer

A single-arm, open-label phase II clinical study of nab-paclitaxel combined with anlotinib in platinum-resistant recurrent ovarian cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054329
Enrollment
Unknown
Registered
2021-12-14
Start date
2020-10-10
Completion date
Unknown
Last updated
2022-11-14

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:albumin paclitaxel combined with anlotinib

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer; 2. It is platinum-resistant recurrent ovarian cancer (platinum-free interval less than 6 months); 3. Never used an albumin-paclitaxel-containing regimen or used an albumin-paclitaxel-containing regimen for more than 4 weeks; 4. The subject received at least 4 weeks after the last chemotherapy, and the toxicity other than alopecia or vitiligo must be recovered to grade 1 or less; 5. Objectively measurable lesions defined by RECIST1.1; 6. Aged above 18 years old and below 75 years old (including 18 years old and 75 years old); 7. Physical condition: ECOG score 0-1; 8. Expected survival time >= 3 months, and can be followed up; 9. Good organ function. The results of routine blood, liver and kidney function laboratory tests meet the following criteria: white blood cells (WBC) >= 3.5x10^9/L, platelets (PLT) >= 80x10^9/L, neutrophil (ANC) >= 1.5x10^9/L, Hemoglobin (HGB) >= 80g/L, Aspartate aminotransferase (AST) =60 ml/min (calculated according to the Cockcroft-Gault formula); 10. Subjects have signed an informed consent form, stating that they understand the purpose of the research, research procedures and research content, and voluntarily participate in the research, and are willing to abide by the constraints specified in this research protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with brain metastases with obvious symptoms; 2. Known allergy to any drug in the study; 3. Those with active ulcer, intestinal perforation, intestinal obstruction, unhealed fracture; 4. Unstable angina pectoris, myocardial infarction, grade III-IV cardiac insufficiency (NYHA criteria) occurred within 6 months before enrollment; 5. Those who have a history of gastrointestinal perforation or have undergone major surgery within 28 days before enrollment; 6. Hypertension that is not controlled by drugs; 7. There is an uncontrolled active infection; 8. There was obvious peripheral neuropathy in the past; 9. Suffering from mental illness or other conditions, such as uncontrollable heart or lung disease, diabetes, etc., and cannot cooperate with the research treatment and monitoring requirements; 10. With a history of other primary malignant tumors (except for non-malignant skin melanoma); 11. Those with obvious active bleeding.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Countries

China

Contacts

Public ContactLi Yanfang

Sun Yat-Sen University Cancer Center

zhouyun@sysucc.org.cn+86 13024109190

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026