Fact CheckerSign in

NCT05173272RecruitingPhase 3

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

A Prospective Randomized Controlled Trials of Neoadjuvant Chemotherapy Combined With Serplulimab Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer

Source: ClinicalTrials.gov · Last updated 27 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
286 (estimated)
First submitted
26 Dec 2021
Start date
24 Jul 2023
Primary completion date
28 Dec 2027
Lead sponsor
Sichuan Cancer Hospital and Research Institute
NCT number
NCT05173272

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 286
  • From 24 Jul 2023 to the primary completion date, 28 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pregnant or breastfeeding female patients (women of child-bearing potential must confirm that the pregnancy test is negative within 7 days before the first administration. If it is positive, ultrasound examination must be performed to exclude pregnancy), or women of child-bearing potential who refused to receive contraceptive measures
  • Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication

Other illness

  • Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin 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 systematic treatment
  • Patients with≥Grade 1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 5.0
  • Had severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug intervention within 6 months
  • It is known to have a history of allergies to research drugs or drug components
  • Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent

Other

  • Has clinically significant thyroid dysfunction before enrollment;
  • The investigator believes that the patient is not suitable for participating in this clinical research

Who the study is looking for

  • 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 measurable target 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 aspartate aminotransferase (AST) ≤2.5×ULN Serum creatinine (Cr) ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50mL/min
  • Cardiac Function: left ventricular ejection fraction (LVEF) \>=50%;
  • Patients voluntarily participated in the study and signed informed consent

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sicchuan cancer hospital
Coordinator of this site? Confirm its status
ChengduChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.