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Observational clinical study of apatinib for advanced malignant solid tumors

Observational clinical study of apatinib for advanced malignant solid tumors

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017375
Enrollment
Unknown
Registered
2018-07-27
Start date
2018-08-27
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

advanced malignant solid tumors

Interventions

Sponsors

The First Hospital Affiliated to AMU/Southwest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients with recurrent/metastatic advanced gastric cancer, colon cancer, liver cancer, lung cancer, ovarian cancer, cervical cancer, breast cancer, osteosarcoma, soft tissue sarcoma or other refractory solid tumors diagnosed by histology or cytology; 2. Aged 18 years old or above, male or female; 3. ECOG PS: 0-3 points; 4. The expected survival period is greater than or equal to 12 weeks; 5. The main organ function levels meet the following criteria: The main organs function normally, that is, the following criteria are met: (1) Blood routine examination standards should be consistent with: ANC=1.5×10^9/L, PLT=75×10^9/L, Hb=90g/L (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli); (2) Biochemical examination should meet the following criteria: TBIL<1.5×ULN, ALT, AST<2.5×ULN patients with liver metastasis can <5×ULN, BUN and Cr=1×ULN or endogenous creatinine clearance =50ml/min (Cockcroft-Gault formula); 6. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last to test drugs after 8 weeks, using appropriate methods of contraception; 7. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.

Exclusion criteria

Exclusion criteria: 1. Symptomatic brain metastasis, cancerous meningitis (patients with brain metastasis who have completed treatment and stable symptoms for 21 days before enrollment,those patients can be enrolled, but need to be confirmed by brain MRI, CT or venography to have no cerebral hemorrhage symptoms); 2. People with high blood pressure who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 3. myocardial ischemia with above grade II or myocardial infarction, arrhythmia 4. Have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 5. Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 6. A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, significantly affecting the use and absorption of drugs); 7. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 8. Urine routinely showed urinary protein = ++ or confirmed 24-hour urine protein quantitation > 1.0 g; 9. Patients with a history of psychotropic substance abuse who cannot be cured or who have mental disorders; 10. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 11. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.

Design outcomes

Primary

MeasureTime frame
progression-free survival ;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactXuequan Huang

The First Hospital Affiliated to AMU/Southwest Hospital

742676160@qq.com+86 13023309167

Outcome results

None listed

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