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A clinical study of apatinib and cisplatin with concurrent radiotherapy for treatment of cervical cancer

A clinical study of apatinib and cisplatin with concurrent radiotherapy for treatment of cervical cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016391
Enrollment
Unknown
Registered
2018-05-30
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-06-05

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

Conditions

cervical cancer

Interventions

treatment group:apatinib+cisplatin+radiotherapy
control group:cisplatin+radiotherapy

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 35-65 years; 2. Pathology confirmed as cervical squamous cell carcinomaand FIGO stage is IIb or III; 3. ECOG (Eastern Cooperative Oncology Group) 0~2; 4. No surgery history; 5. The damage from other treatments had been recovered, with the interval between nitrocellulose or mitomycin for up to six weeks. To receive other cytotoxic drugs, radiation or surgery for four weeks, and the wound has healed completely; 6. The main organ function is normal, which meets the following criteria: (1) the standard of blood test should be met (14 days without blood transfusion and blood products, no G-CSF and other hematopoietic stimulation factor correction): Hb=90g/L;ANC=1.5×10^9/L;PLT=80×10^9/L; (2) biochemical inspection shall meet the following criteria: TBIL 45 ml/min (the Cockcroft Gault formula); 7. Participants voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. People with high blood pressure and can not be reduced to a normal range (systolic > 140 mmHg, diastolic > 90 mmHg). A person with a history of unstable angina; In the first 3 months of screening, the new diagnosis was a cardiac myocardial infarction in the first six months. Cardiac arrhythmias (including QTcF greater than 470 ms) require long-term use of arrhythmias and the New York heart association (New York heart association); 2. Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 3. The coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency is used anticoagulants or vitamin K antagonists such as warfarin and heparin or its analogues treatment; 4. The central nervous system with symptoms and activity is transferred; 5. The researchers judged other conditions that could affect clinical research and the results of the study

Design outcomes

Primary

MeasureTime frame
Objective response rate;disease control rate;

Secondary

MeasureTime frame
progression-free survival;Overall survival;3-year survival rate;5-year survival rate;The quality of life;drug safety;Tumor markers;

Countries

China

Contacts

Public ContactHongbing Ma

The Second Affiliated Hospital of Xi'an Jiaotong University

mhbxian@126.com+86 13991845066

Outcome results

None listed

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