Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer

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

The main objective of this study is to determine whether neoadjuvant chemotherapy combined with slulimumab sequential concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced cervical cancer could improve progression-free survival rates.

Women in the experimental arm will receive neoadjuvant chemotherapy (cisplatin plus paclitaxel) combined with slulimumab every 21 days during 2 cycles followed by concurrent chemoradiation therapy. Women in the control arm will receive concurrent chemoradiation therapy alone.

286 patients will be recruited during 2 years, with 3 years of follow up period.

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
    China

    Active - Recruiting

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