Tests chemotherapy with immunotherapy before chemoradiation for advanced cervical cancer
Tests chemotherapy plus an immunotherapy drug before chemoradiation in women with advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 or older with locally advanced cervical cancer who have had no treatment yet. It compares chemotherapy plus serplulimab before chemoradiation with chemoradiation alone.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Cervical cancer (adenocarcinoma, adenosquamous or squamous), FIGO 2018 stage Ib3-IIIc2, with at least one measurable tumour lesion
- Earlier treatment
- No prior treatment for the cancer
Main reasons for not taking part
- Pregnant or breastfeeding, or refusing contraception if able to have children
- Another malignant tumour (except cured skin basal cell or squamous cell cancer, or carcinoma in situ)
- Active infection needing treatment, HIV infection, or viral hepatitis needing treatment
- Peripheral neuropathy of grade 1 or higher
- Serious heart or blood vessel disease within the last 6 months
Read by machine on 11 November 2026.
Where in China
- Sicchuan cancer hospitalChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sichuan Cancer Hospital and Research Institute
- Trial code
- NCT05173272
- Record updated
- 27 December 2023
- Original description
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.Read full original descriptionShow less
A Prospective Randomized Controlled Trials of Neoadjuvant Chemotherapy Combined With Serplulimab Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer
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.
Inclusion: 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.
Exclusion: 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; 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; Has clinically significant thyroid dysfunction before enrollment; The investigator believes that the patient is not suitable for participating in this clinical research.