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An prospective, single-arm, multi-center clinical trial of Apatinib combined with capecitabine in the treatment of advanced ovarian cancer

An prospective, single-arm, multi-center clinical trial of Apatinib combined with capecitabine in the treatment of advanced ovarian cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17012186
Enrollment
Unknown
Registered
2017-07-30
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Ovarian cancer

Interventions

none:combined Capecitabine

Sponsors

The Second People's Hospital of Hefei
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged =18 years old, female; 2. The pathological/cytology diagnosis of Advanced ovarian cancer 3. Have at least one measurable lesion (RECIST 1.1); 4. patients who have previously received =first line of standard chemotherapy and have a failure on the that treatment; "Treatment failure" definition: (1)disease progression during treatment or 6 months after the last treatment ,imaging or clinical evidence clearly show disease progressing; (2) patients giving up the standard Treatment,according to CTCAE 4.0 criterion,due to inability to tolerate adverse events, the intolerance of serious hematological adverse events upto grade IV degree (platelet reduction of more than III degree) or non-hematological adverse event more than III degree, and the researchers judge the subjects were still unable to tolerate the original regimen. 5. ECOG PS 0-2 points; 6. Expected survival = 3 months; 7. The main organ function, that meet the following criteria: (1) HB>=90 g/L; ANC>=1.5*10^9/L; PLT>=80*10^9/L; (2) TBIL 45 ml/min (Cockcroft-Gault formula); 8. women of childbearing age must have taken reliable contraceptive measures or 7 days before the group performed a pregnancy test (serum or urine), and the result is negative, and willing to experiment and during the last eight weeks after administration of the test drugs using appropriate methods contraception; 9. The subjects voluntarily joined the study, and informed consent; 10. According to the program requirements ,Patients are expected to take follow-up about their efficacy and adverse reactions.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating; 2. After suffering from high blood pressure and antihypertensive medications can not fall within the normal range (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) above the level of suffering I myocardial ischemia,myocardial infarction, arrhythmia or Class II cardiac sufficiency; 3. coagulation abnormalities (INR> 1.5 or APTT>1.5ULN + 4 seconds, or APTT>1.5 ULN), having bleeding tendency,or treated with thrombolysis and anticoagulation; 4. Patients with clear gastrointestinal bleeding concerns(including the following situations: local active ulcerative lesions, and defecate occult blood (++)); A period of 6 months prior to the start of the study gastrointestinal bleeding event has occurred; 5. Accompanied by the central nervous system transfer; 6. Investigator judgment that may affect the conduct of clinical studies and case studies determined.

Design outcomes

Primary

MeasureTime frame
DCR;ORR;

Countries

China

Contacts

Public ContactBi Jinling

The Second People's Hospital of Hefei

bijinling2011@126.com+86 13739292676

Outcome results

None listed

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