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Dose escalating study of lobaplatin concurrent with radiotherapy for locally advanced cervical cancer

Dose escalating study of lobaplatin concurrent with radiotherapy for locally advanced cervical cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040113
Enrollment
Unknown
Registered
2020-11-21
Start date
2020-11-07
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

Cervical cancer

Interventions

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Pathologically confirmed any type of cervical cancer; 3. Clinically 2018 FIGO stage IB3-IVA; 4. Have never received radiotherapy, chemotherapy, target therapy and immune therapy for cervical cancer; 5. At least one measurable lesion; 6. ECOG 0-1; 7. Expected survival time >=6 months; 8. Baseline laboratory tests meet the following criteria: (1) Bone marrow function: WBC>=4.0x10^9/L, ANC>=2.0x10^9/L, PLT>=100x10^9/L, Hb>=80g/L; (2) Liver function: serum bilirubin =60 ml/min (calculated by Cockcroft-Gault formula); (3) Coagulation function: International standard ratio of prothrombin time (INR) 1.5 ULN; (4) Heart function: Electrocardiogram is generally normal. 9. Contraception during and within 6 months after treatment. Non-lactation period; 10. The patient signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) Allergies to the study drug; (2) The researchers determined that chemoradiotherapy could not be tolerated; (3) Malignant tumor of other histological origin in the previous 5 years, except for adequately treated carcinoma in situ of the cervix and basal cell or squamous cell carcinoma of the skin; (4) Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure,> grade II by New York heart association classification of heart disease, severe arrhythmia, and pericardial effusion; (5) Participated in any other clinical trials within 4 weeks before study enrollment; (6) Received surgery within 4 weeks before enrollment, or the surgical wound has not fully healed; (7) Haemorrhage occurs within 4 weeks before enrollment (blood transfusion or hospitalization is required); (8) Severe infection requiring intravenous antibiotics, antifungal or antiviral treatment; (9) Long-term use of anticoagulants or vitamin K antagonists such as Warfarin, heparin or their analogues is required, but does not include use of small doses of warfarin (<=1 mg/day) or aspirin (<=100 mg/ day) for preventive purposes; (10) Suffering from mental illness and poor compliance; (11) Cases that were not considered suitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
dose limiting toxicity;

Countries

China

Contacts

Public ContactXiaofan Li

Beijing Cancer Hospital

lxflp@163.com+86 010-88196991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 23, 2026