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

NCT05883670 | Unknown

• 1 other identifier: ASTRUM-CC02
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate is defined as the percentage of patients with Complete Response or Partial Response, as assessed by Response Evaluation Criteria in Solid Tumors v.1.1 criteria or immune Response Evaluation Criteria in Solid Tumors v.1.1 criteria by investigators.

  Up to approximately 24 months

Secondary Outcomes (7)

• Progression free survival (PFS)

  Up to approximately 24 months

• Overall Survival (OS)

  Baseline up to approximately 36 months

• Duration of response (DOR)

  Up to approximately 24 months

• Time to the first disease progression

  Up to approximately 24 months

• 1-year and 2-year Progression free survival Rate

  Baseline up to approximately 24 months

Study Arms (1)

Cohort 1

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.

Drug: Serplulimab

Interventions

Serplulimab DRUG

Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Also known as: HLX10

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients Histologically or cytologically confirmed advanced, recurrent or metastatic cervical cancer，who received at least 1 prior systemic therapies in the recurrent or metastatic setting，tumor progression or recurrence after treatment with therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Beihua Kong, MD.PhD.

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beihua Kong, MD.PhD.

CONTACT

+8618560081888; kongbeihua@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: June 1, 2023
• Study Start: March 9, 2023
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)