Last updated: December 25, 2023
Sponsor: Sichuan Cancer Hospital and Research Institute
Overall Status: Active - Recruiting
Phase
3
Condition
Dysfunctional Uterine Bleeding
Pelvic Cancer
Vaginal Cancer
Treatment
CCRT
Neoadjuvant Therapy
Brachytherapy
Clinical Study ID
NCT05173272
KY-2021-109
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years old
- Patients must have histologically confirmed cervical cancer with adenocarcinoma,adenosquamous or squamous histology and FIGO 2018 Ib3-IIIc2.
- According to the RECIST 1.1 standard, the subject must have at least one measurabletarget lesion
- No prior treatment
- Expected survival period ≥ 3 months
- ECOG score: 0-1
- No obvious signs of hematological diseases, ANC≥1.5×10^9/L, platelet count≥100×10^9/L,Hb≥90g/L, WBC≥3.0×10^9/L, and no bleeding tendency before enrollment;
- Adequate hepato-renal function is needed, including: Total bilirubin (TBIL)≤1.5×ULN (Gilbert syndrome allows ≤5×ULN) Alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≤2.5×ULN Serum creatinine (Cr) ≤ 1.5 × ULN or endogenouscreatinine clearance ≥ 50mL/min
- Cardiac Function: left ventricular ejection fraction (LVEF) >=50%;
- Patients voluntarily participated in the study and signed informed consent
Exclusion
Exclusion Criteria:
- Pregnant or breastfeeding female patients (women of child-bearing potential mustconfirm that the pregnancy test is negative within 7 days before the firstadministration. If it is positive, ultrasound examination must be performed to excludepregnancy), or women of child-bearing potential who refused to receive contraceptivemeasures
- Combined with other malignant tumors, except for cured skin basal cell carcinoma orskin squamous cell carcinoma or carcinoma in situ of any other part
- Existence of any bone marrow dysplasia and other abnormal hematopoietic diseases
- Active infections, HIV infections, and viral hepatitis that require systematictreatment
- Patients with≥Grade 1 peripheral neuropathy according to the National Cancer InstituteCommon Toxicity Criteria (NCI-CTC) Version 5.0
- Had severe cardiovascular diseases such as cerebrovascular accident, myocardialinfarction, hypertension that cannot be controlled after drug intervention, unstableangina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug interventionwithin 6 months
- It is known to have a history of allergies to research drugs or drug components
- Has clinically significant thyroid dysfunction before enrollment;
- Has participated in other anti-tumor intervention clinical trials within 30 daysbefore the first medication
- Have a clear history of dementia, mental state changes or any mental illness that willhinder understanding or informed consent
- The investigator believes that the patient is not suitable for participating in thisclinical research
Study Design
Total Participants: 286
Treatment Group(s): 3
Primary Treatment: CCRT
Phase: 3
Study Start date:
July 24, 2023
Estimated Completion Date:
December 28, 2028
Connect with a study center
Sicchuan cancer hospital
Chengdu, Sichuan 610000
ChinaActive - Recruiting

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