Combining chemotherapy and immunotherapy for advanced cervical cancer treatment
A Prospective Randomized Controlled Trials of Neoadjuvant Chemotherapy Combined With Serplulimab Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer
This study is testing if combining chemotherapy with a new immunotherapy can help women with advanced cervical cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sichuan Cancer Hospital and Research Institute Academic / other |
| Drugs / interventions | slulimumab, chemotherapy |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT05173272 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically confirmed cervical cancer of specific types and stages.
Not a fit: Patients who are pregnant or breastfeeding, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for women with advanced cervical cancer.
How similar studies have performed: Other studies have shown promise in combining chemotherapy with immunotherapy for various cancers, suggesting potential success for this approach in cervical cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chengdu, Sichuan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.