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Randomized controlled clinical study for the efficacy and safety of neoadjuvant chemotherapy combined with concurrent chemoradiotherapy and concurrent chemoradiotherapy for locally advanced cervical cancer (lump=4cm)

Randomized controlled clinical study for the efficacy and safety of neoadjuvant chemotherapy combined with concurrent chemoradiotherapy and concurrent chemoradiotherapy for locally advanced cervical cancer (lump=4cm)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023257
Enrollment
Unknown
Registered
2019-05-19
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-20

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 :neoadjuvant chemotherapy combined with concurrent chemoradiotherapy

Sponsors

Guizhou Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1 Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma; 2 FIGO staging, patients with cervical cancer (tumor = 4cm) above IB2, IIA2 and IIB; 3 Carlisle score = 70 points; 4 Aged 18 to 65 years; 5 Bone marrow hematopoietic function is normal (WBC>4.0×10^9/L, PLT=100×10^9/L, Hbt>70g/L); 6 Liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (AST) < 1.5 times the upper limit of normal (ULN); total bilirubin < 1.5 × ULN; renal function: serum creatinine <1.5 × ULN; 7 Can understand the study and has signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1 There have been invasive malignancies before: except for non-malignant melanoma skin cancer; 2 Has undergone systemic chemotherapy in the last 3 years; 3 Simultaneously receive chronic systemic immunotherapy or hormone therapy other than this study; previously had a history of pelvic or abdominal radiation therapy; 4 Has a history of surgery; 5 Pregnant women, lactating women; 6 Have the following serious, active concurrent diseases: - Unstable angina or/and congestive heart failure requiring hospitalization in the past 6 months; - An acute bacterial or fungal infection at the time of registration, requiring intravenous antibiotic treatment; - Worsening of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization or impeding research; - Acquired immunodeficiency disease (patients diagnosed with AIDS, or patients suspected of having AIDS, refused to be tested for human immunodeficiency virus); Other immunocompromised states (eg organ transplantation, long-term use of glucocorticoids). 7 The patient has physical or mental illness, or has no civil capacity or limited capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
efficacy evaluation;PFS;

Secondary

MeasureTime frame
Treatment-related toxicity;

Countries

China

Contacts

Public ContactLi Fenghu

Affiliated Hospital of Guizhou Medical University/ Guizhou Cancer Hospital

769654418@qq.com+86 0851 86513080

Outcome results

None listed

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