Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer

Shandong University

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Drug: Serplulimab

Study type: Observational

Funder types: Other

Identifiers

NCT05883670

ASTRUM-CC02

Details and patient eligibility

About

This study is a Prospective, Multicenter, non-interventive Real-world Study to evaluate the efficacy and safety of the treatment of Serplulimab in patients with Advanced,Recurrent and Metastatic Cervical Cancer. Approximately 118 eligible subjects are planned to be enrolled across all sites.

Enrollment: 118 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

118 participants in 1 patient group

Cohort 1

Description:

The medication plan is determined by gynecological oncology or oncology physician. Select the treatment plan containing serplulimab (single drug and/or combination), the other anti-tumor treatment schemes without intervention. The recommended dose of serplulimab is 300 mg IV, Day1 of each cycle. Apply the drug on the first day of each cycle until the disease progresses or intolerable toxicity occurs.The combined drugs is decided by the doctor. In this non-interventive study, do not change or interfere with the current medical treatment of the recruited patients.

Treatment:

Drug: Serplulimab