Cervical CancerNCT05883670
Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer
An observational study of Cervical Cancer, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Serplulimab
- Type of treatment
- Injection or infusion
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Beihua Kong, MD. PhD., +8618560081888, kongbeihua@sdu.edu.cn
About this study
Official title: 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 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
- Being tested
- Serplulimab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Also called HLX10
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 24 months
Secondary outcomes (7)
Progression free survival (PFS)
Progression free survival is defined as the time from the first day of serplulimab administration to progression disease or death，whichever occurs first, by the investigator according to Response Evaluation Criteria in Solid Tumors v.1.1 criteria or immune Response Evaluation Criteria in Solid Tumors v.1.1 criteria.
Measured: Up to approximately 24 months
Overall Survival (OS)
OS, defined as the time from initiation of study treatment to death from any cause. To assess clinical effectiveness of any serplulimab single used or combined therapy involved in this study by assessment of overall survival (OS) in patients with cervical Cancer. Time intervals for tumor assessment is every 6 or 12 week .
Measured: Baseline up to approximately 36 months
Duration of response (DOR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 24 months
Time to the first disease progression
Ddefined as the interval between the date of the initial medication and the time of imaging progression.
Measured: Up to approximately 24 months
1-year and 2-year Progression free survival Rate
PFS is defined as the time from first administration to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS Rate was defined as the percentage of participants that are PFS event-free over 1-year and 2-year.
Measured: Baseline up to approximately 24 months
1-year and 2-year Overall Survival Rate
OS, defined as the time from initiation of study treatment to death from any cause. OS Rate was defined as the percentage of participants that are OS event-free over 1-year and 2-year.
Measured: Baseline up to approximately 24 months
1-year and 2-year Disease Control Rate
Percentage of all evaluable Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD) from first administration to 1-year and 2-year.
Measured: Baseline up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start9 Mar 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beihua Kong, Shandong University
- Investigators
- Beihua Kong, MD.PhD., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883670
- Sponsor's protocol ID
- ASTRUM-CC02
- Status last verified
- May 2023
- First submitted
- 6 Mar 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Efficacy and Safety of Serplulimab（HLX10）in Patients With Advanced, Recurrent and Metastatic Cervical Cancer：A Prospective, Multicenter, Non-interventive Real-world Study
- ClinicalTrials.gov ID
- NCT05883670
- Acronym / sponsor ID
- ASTRUM-CC02
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: SerplulimabThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerplulimabAlso: HLX10Serplulimab 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. | Drug | Cohort 1 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
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.
7 secondary outcomes
Progression free survival (PFS)
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Baseline up to approximately 36 months
Duration of response (DOR)
Time frame: Up to approximately 24 months
Time to the first disease progression
Time frame: Up to approximately 24 months
1-year and 2-year Progression free survival Rate
Time frame: Baseline up to approximately 24 months
1-year and 2-year Overall Survival Rate
Time frame: Baseline up to approximately 24 months
1-year and 2-year Disease Control Rate
Time frame: Baseline up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beihua Kong, MD.PhD. principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beihua Kong, MD.PhD. (+8618560081888, kongbeihua@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.