Actively Recruiting
Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer
Led by Sichuan Cancer Hospital and Research Institute · Updated on 2023-12-27
286
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed cervical cancer with adenocarcinoma, adenosquamous, or squamous histology and FIGO 2018 stage Ib3-IIIc2
- At least one measurable target lesion according to RECIST 1.1
- No prior cancer treatment
- Expected survival of 3 months or more
- ECOG performance status of 0 or 1
- No significant blood disorders: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L, WBC ≥ 3.0 x 10^9/L, and no bleeding tendency
- Adequate liver and kidney function: Total bilirubin ≤ 1.5 x ULN (Gilbert syndrome ≤ 5 x ULN), ALT and AST ≤ 2.5 x ULN, serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Cardiac function with left ventricular ejection fraction ≥ 50%
- Voluntary participation with signed informed consent
You will not qualify if you...
- Pregnant or breastfeeding women, or women of child-bearing potential not using contraception
- Having other malignant tumors except cured basal cell or squamous cell skin cancer or carcinoma in situ
- Presence of bone marrow disorders or abnormal blood-forming diseases
- Active infections including HIV or viral hepatitis requiring treatment
- Peripheral neuropathy grade 1 or higher per NCI-CTC version 5.0
- Severe cardiovascular diseases within past 6 months such as stroke, heart attack, uncontrolled hypertension, unstable angina, heart failure (NYHA 2-4), or arrhythmia needing medication
- Known allergy to study drugs or their components
- Significant thyroid dysfunction before enrollment
- Participation in other anti-cancer clinical trials within 30 days before first treatment
- History of dementia, mental illness, or cognitive issues hindering understanding or consent
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sicchuan cancer hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
G
Guonan Zhang
CONTACT
H
Hong Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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