Combining chemotherapy and immunotherapy for advanced cervical cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of neoadjuvant chemotherapy combined with slulimumab followed by concurrent chemoradiation therapy in improving progression-free survival rates in women with locally advanced cervical cancer. Participants in the experimental group will receive two cycles of chemotherapy with cisplatin and paclitaxel along with slulimumab, while the control group will undergo standard concurrent chemoradiation therapy alone. A total of 286 patients will be recruited over two years, with follow-up lasting three years to assess outcomes.

Why it matters

Who can join: the full rules

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 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 Criteria:

* 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
* 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
* Has clinically significant thyroid dysfunction before enrollment;
* Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication
* Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent
* The investigator believes that the patient is not suitable for participating in this clinical research

Where it's running

• Sicchuan cancer hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: Guonan Zhang — Sichuan Cancer Hospital and Research Institute
• Study coordinator: Guonan Zhang
• Email: zhanggn@hotmail.com
• Phone: 86-13881866599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.