Neoadjuvant chemotherapy with PD-1 and radiotherapy for advanced cervical cancer
Neoadjuvant Chemotherapy Combined With PD-1 Antibody + Radical Radiotherapy in Unresectable Locally Advanced Cervical Cancer Patients
This study is testing a new treatment plan that combines chemotherapy and a special antibody with radiation therapy to see if it helps people with advanced cervical cancer who can't have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, camrelizumab, ipilimumab, Immunotherapy, radiation, prednisone |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05554276 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of neoadjuvant chemotherapy combined with PD-1 antibody therapy followed by radical radiotherapy in patients with locally advanced cervical cancer. The study involves administering three cycles of chemotherapy alongside PD-1 treatment before standard radiotherapy to potentially reduce tumor size and improve treatment outcomes. It is a prospective, single-arm, phase II trial conducted at a single center, focusing on patients who are not candidates for surgical intervention due to the extent of their disease. The trial aims to evaluate the safety and efficacy of this combined approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-70 with unresectable cervical squamous cell carcinoma at stage IIB or above.
Not a fit: Patients with active autoimmune diseases may not benefit from this study due to potential complications from the treatment.
Why it matters
Potential benefit: If successful, this treatment could improve the efficacy of radiotherapy and reduce side effects for patients with advanced cervical cancer.
How similar studies have performed: While similar approaches have shown promise in other studies, this specific combination of treatments is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who were pathologically diagnosed with cervical squamous cell carcinoma and were assessed as unresectable. Exclusion Criteria: * Any active or present autoimmune disease (eg, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism)
Where this trial is running
Shanghai
- Vitalbeam — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jie Fu, Dr
- Email: fujie74@sjtu.edu.cn
- Phone: 8602124058972
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.