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Phase II exploratory study on clinical effects and biomarkers of bevacizumab combined with concurrent chemoradiotherapy in the treatment of local advanced cervical cancer

Phase II exploratory study on clinical effects and biomarkers of bevacizumab combined with concurrent chemoradiotherapy in the treatment of local advanced cervical cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090725
Enrollment
Unknown
Registered
2024-10-12
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

cervical cancer

Interventions

experimental group:Cisplatin 40 mg/m2 Iv Day 1, qw for 5 weeks
Bevacizumab 10 mg/kg a Day 1, q2w, a total of 3 courses Radiotherapy: Pelvic radiotherapy 45Gy, 25 times, 5 times/week
After loading treatment 40Gy, 1-2 LDR or 30Gy5 HDR

Sponsors

Fuyang City Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following criteria to be enrolled: 1) Age = 18 years old, less than or equal to 75 years old, gender unlimited; 2) Confirmed cervical cancer by histopathological examination; 3) FIGO stages of 2018 were IB3, IIA2-IVA; 4) No previous surgery, radiotherapy, systemic therapy, immunotherapy; 5) No distant organ metastasis; 6) Have at least one measurable lesion (compliant with RECISIT version 1.1); 7) Expected survival time =12 weeks; 8) ECOG physical condition 0-2 points; 9) The subjects' major organ functions were normal: hemoglobin =100 g/L, WBC=4× 109 /L, platelets =100× 109 /L, ALT and AST< 1.5 times the upper limit of normal (ULN), total bilirubin <1.5×ULN, serum creatinine <1.5×ULN. 10) Patients or family members can understand the study protocol and are willing to participate in the study, and sign a written informed consent; 11) Patients whom the researchers believe could benefit.

Exclusion criteria

Exclusion criteria: Patients were excluded if they met any of the following criteria: 1) Previous hysterectomy 2) People who are known to be allergic to any component of treatment regimen drugs and excipients; 3) Endovascular brachytherapy or interstitial brachytherapy is not possible due to anatomy, tumor shape, or contraindications 4) Uncontrolled hypertension, systolic blood pressure > 150mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy and active bleeding, pulmonary hemorrhage, hemoptysis or bloody ascites; 5) Patients with a history of grade 4 venous embolism (including pulmonary embolism); 6) Severe uncontrolled recurrent infections include abdominal infections, or other serious uncontrolled concomitant diseases (such as uncontrolled diabetes, cardiovascular and cerebrovascular diseases, severe gastrointestinal diseases, etc.); 7) Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 8) Known history of psychotropic substance abuse or drug use; 9) Pregnant or lactating patients; 10) Present or present with other malignancies within 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ), and T1 (tumor infiltrating basal membrane); 11) The researcher decides that it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Complete Remission;Adverse Events;

Secondary

MeasureTime frame
progression free survival;objective response rate;Disease control rate;2-year progression-free survival;Overall survival at 2 years;

Countries

China

Contacts

Public ContactGuangming Wang

Anhui Fuyang city Cancer Hospital

451654782@qq.com+86 137 0558 5544

Outcome results

None listed

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