Combining immunotherapy and chemotherapy for advanced cervical cancer
Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial
This study is testing if adding a new immune treatment to standard chemotherapy can help people with advanced cervical cancer live longer and reduce the chances of their cancer coming back.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06093438 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adding neoadjuvant immunotherapy to neoadjuvant chemotherapy in patients with locally advanced cervical cancer who are at high risk for recurrence. The focus is on patients with FIGO stage IIIB-IVA cervical cancer, where the goal is to reduce the risk of distant metastasis and improve disease-free survival rates. Participants will receive Toripalimab, a PD-L1 inhibitor, alongside standard chemotherapy before undergoing definitive chemoradiotherapy.
Who should consider this trial
Good fit: Ideal candidates are untreated women with locally advanced cervical cancer, specifically those with FIGO stage IIIB-IVA disease.
Not a fit: Patients with metastatic or recurrent cervical cancer or those who have received prior treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival outcomes for patients with advanced cervical cancer.
How similar studies have performed: While the combination of immunotherapy and chemotherapy is being explored in various cancers, this specific approach in locally advanced cervical cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Untreated locally advanced cervical cancer patients with clear pathological diagnosis 2. 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4. Life expectancy \> 6 months 5. Able to tolerate concurrent chemoradiotherapy assessed by researches 6. No obvious active bleeding; 7. Adequate hematological, renal and hepatic functions: 8. No concomitant malignancies 9. Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period; 10. Voluntarily-signed informed consent. Exclusion Criteria: 1. Concomitant other malignancies; 2. Patients with metastatic or recurrent disease; 3. Patients received any form of treatment before enrollment; 4. Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections; 5. Impaired hematological, renal or hepatic functions: 1. Hemoglobin \< 9.0 g/dl 2. Neutrophils \< 2000 cells/μl; Leukocytes \< 4 × 109/L 3. Platelets \> 100 × 109/L 4. Serum ALT/AST \> 2.5×UNL 5. Serum Total bilirubin \> 1.5× UNL g. Serum urea nitrogen (BUN) \> 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) \> 1.5 × upper normal limit (UNL) 6. Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease; 7. Patients with uncontrolled mental diseases; 8. Pregnant or lactating woman; 9. Participating in other clinical trials; 10. Anyone considered not suitable for enrollment by principal investigator;
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jie Chen — Tianjin Medical University Cancer Institute and Hospital
- Study coordinator: Yuanjie Cao
- Email: cyjro325@gmail.com
- Phone: +86-18522123151
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.