Evaluating Serplulimab for Advanced Cervical Cancer Treatment
Evaluate Efficacy and Safety of Serplulimab（HLX10）in Patients With Advanced, Recurrent and Metastatic Cervical Cancer：A Prospective, Multicenter, Non-interventive Real-world Study
This study is testing a new treatment called Serplulimab to see if it can help people with advanced cervical cancer who have already tried other therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shandong University Academic / other |
| Drugs / interventions | Serplulimab |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05883670 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of Serplulimab in patients with advanced, recurrent, and metastatic cervical cancer. Approximately 118 eligible participants will be enrolled across multiple centers, focusing on those who have received at least one prior systemic therapy. The study will monitor patient outcomes in a real-world setting, providing valuable insights into the treatment's effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced, recurrent, or metastatic cervical cancer who have previously undergone systemic therapy.
Not a fit: Patients with a life expectancy of less than three months or those currently participating in another clinical study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with advanced cervical cancer who have limited alternatives.
How similar studies have performed: While this study is focused on a specific treatment, similar observational studies have shown promise in evaluating real-world efficacy of cancer therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years at time of study entry. * Histologically or cytologically confirmed advanced, recurrent or metastatic cervical cancer. * Received at least 1 prior systemic therapies in the recurrent or metastatic setting. Tumor progression or recurrence after treatment with therapy. * ECOG performance status of 0 or 1. * Patient must have at least one measurable disease as defined by RECIST 1.1. * Ability to provide written and signed informed consent. Exclusion Criteria: * Pregnant or lactating women. * Life expectancy \< 3 months * Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 14 days from the end of treatment in the previous clinical study. * Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody. * The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Beihua Kong, MD.PhD. — Qilu Hospital of Shandong University
- Study coordinator: Beihua Kong, MD.PhD.
- Email: kongbeihua@sdu.edu.cn
- Phone: +8618560081888
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.