Recurrent or Metastatic Cervical CancerNCT06155422
A Prospective Real-world Study of Cadonilimab in Patients With Recurrent or Metastatic Cervical Cancer
An observational study of Recurrent or Metastatic Cervical Cancer, run by Gang Chen (101199).
Trial summary
This real-world study included all patients with recurrent or metastatic cervical cancer who used Cadonilimab in clinical practice, regardless of treatment lines and combination with different treatments. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Recurrent or Metastatic Cervical Cancer
- What is being tested?
- Cadonilimab
- How many people
- 670 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2023to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 1. recurrent or metastatic cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy, no prior systemic therapy for persistent, recurrent or metastatic disease. 2. subjects have demonstrated radiologically confirmed disease progression during or after last treatment, subjects will have no more than 2 lines of systemic therapy in the recurrence or metastatic stages.
Who may be able to join
- The subject must sign the written informed consent form (ICF) voluntarily.
- Aged ≥ 18years, female.
- Histologically or cytologically confirmed cervical cancer, ① recurrent or metastatic (FIGO IVB) cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy, no prior systemic therapy for persistent, recurrent or metastatic disease, or ② subjects have demonstrated radiologically confirmed disease progression during or after last treatment, subjects will have no more than 2 lines of systemic therapy in the recurrence or metastatic stages. neoadjuvant chemotherapy, adjuvant chemotherapy, or Chemotherapy of non-recurrent or metastatic stage chemoradiotherapy,will not be counted as a treatment line number.
- The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma.
- At least 1 measurable lesion per RECIST v1.1, which is applicable for repeated accurate measurement.
- Life expectancy> 12 weeks.
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- Adequate organ function.
- Female patients with fertility must have a urine or serum pregnancy test within 3 days before the first medication (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, based on the serum pregnancy result), and the result is negative. If a fertile female patient has sex with an unsterilized male partner, the patient must use an acceptable contraceptive method since screening and must consent to continued use of the contraceptive method for 120 days after the last administration of the study drug; Whether to stop contraception after this time point should be discussed with the investigator
- Subjects must be willing and able to comply with the scheduled visits, treatment regimens, laboratory tests, and other requirements in the study.
Who cannot join
- Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.
- Other active malignancies within 2 years prior to the first administration. Subjects with locally curable tumors that appear to be cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the breast, were not excluded.
- Have received other study drugs or study devices within 4 weeks prior to the first administration.
- Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study. (It was defined as more than 4 weeks between the first administration of the drug in the study and the last administration of the drug in the previous clinical study or more than 5 half-lives of the drug in the study)
- An active infection requiring systemic therapy.
- Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 1000 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <1000 IU/ mL), and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
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- Known history of active tuberculosis (TB),In patients suspected of having active tuberculosis, chest x-rays, sputum, and clinical signs and symptoms should be examined for exclusion.
- Receipt of live or attenuated vaccination within 30 days prior to the first administration, or plan to receive live or attenuated vaccine during the study.
- There are any of the following cardiovascular and cerebrovascular diseases or risk factors for cardiovascular and cerebrovascular diseases:
- Myocardial infarction, unstable angina pectoris, pulmonary embolism, acute/persistent myocardial ischemia, cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombosis, embolism, or ischemic events that are clinically significant or require pharmacological intervention occurred within 6 months prior to initial administration.
- Symptomatic congestive heart failure (classified as 3 or 4 according to the New York Heart Association functional classification) occurring within 6 months before the first administration.
- Unstable arrhythmias or degree II/III atrioventricular blocks requiring pharmacological intervention occurred within 6 months prior to initial administration.
- Known history of serious hypersensitivity reaction to other monoclonal antibodies.
- Pregnant or lactating women.
- Any condition that the investigator believes may result in a risk of receiving the study drug or combination therapy, or that would interfere with the evaluation of the study drug or with patient safety or analysis of the study results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gang Chen contact
About this study
Official title: Efficacy and Safety of Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) in the Treatment of Recurrent or Metastatic Cervical Cancer: a Multicenter, Prospective, Real-world Study
This real-world study included all patients with recurrent or metastatic cervical cancer who used Cadonilimab in clinical practice, regardless of treatment lines and combination with different treatments. Through follow-up observations, the aim of this study is to analyze the efficacy of Cadonilimab for recurrent or metastatic cervical cancer in the real world, and to explore the differences in the efficacy of Cadonilimab in different stages of treatment, as well as the efficacy of different treatment combinations, so as to provide clinical evidence for the use of Cadonilimab for recurrent or metastatic cervical cancer.
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Being tested
- Cadonilimab
- Medical subject headings
- Recurrence, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
recurrent or metastatic cervical cancer in the first, second or third lines Systematic treatment
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab-treated Recurrent or Metastatic Cervical Cancer | Not described Receives: Drug: Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
Measured: from the first drug administration up to two years
Secondary outcomes (4)
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR and PR and stable disease(SD) per RECIST v1.1.
Measured: from the first drug administration up to two years
progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: from the first drug administration up to two years
overall survival (OS)
Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause.
Measured: from the first drug administration up to two years
Incidence and severity of adverse events(AEs)
Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with other treatments.
Measured: from the first drug administration up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start30 Nov 2023 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Chen (101199)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Chen (101199), Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155422
- Sponsor's protocol ID
- AK104-RWS-002
- Status last verified
- Sep 2023
- First submitted
- 23 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) in the Treatment of Recurrent or Metastatic Cervical Cancer: a Multicenter, Prospective, Real-world Study
- ClinicalTrials.gov ID
- NCT06155422
- Acronym / sponsor ID
- AK104-RWS-002
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Gang Chen (101199)University, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 4 Dec 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 real-world study included all patients with recurrent or metastatic cervical cancer who used Cadonilimab in clinical practice, regardless of treatment lines and combination with different treatments. Through follow-up observations, the aim of this study is to analyze the efficacy of Cadonilimab for recurrent or metastatic cervical cancer in the real world, and to explore the differences in the efficacy of Cadonilimab in different stages of treatment, as well as the efficacy of different treatment combinations, so as to provide clinical evidence for the use of Cadonilimab for recurrent or metastatic cervical cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab-treated Recurrent or Metastatic Cervical Cancer | – | Drug: Cadonilimab |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. recurrent or metastatic cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy, no prior systemic therapy for persistent, recurrent or metastatic disease. 2. subjects have demonstrated radiologically confirmed disease progression during or after last treatment, subjects will have no more than 2 lines of systemic therapy in the recurrence or metastatic stages.
Key inclusion criteria (9 listed)
- The subject must sign the written informed consent form (ICF) voluntarily.
- Aged ≥ 18years, female.
- Histologically or cytologically confirmed cervical cancer, ① recurrent or metastatic (FIGO IVB) cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy, no prior systemic therapy for persistent, recurrent or metastatic disease, or ② subjects have demonstrated radiologically confirmed disease progression during or after last treatment, subjects will have no more than 2 lines of systemic therapy in the recurrence or metastatic stages. neoadjuvant chemotherapy, adjuvant chemotherapy, or Chemotherapy of non-recurrent or metastatic stage chemoradiotherapy,will not be counted as a treatment line number.
- The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma.
- At least 1 measurable lesion per RECIST v1.1, which is applicable for repeated accurate measurement.
Key exclusion criteria (15 listed)
- Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.
- Other active malignancies within 2 years prior to the first administration. Subjects with locally curable tumors that appear to be cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the breast, were not excluded.
- Have received other study drugs or study devices within 4 weeks prior to the first administration.
- Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study. (It was defined as more than 4 weeks between the first administration of the drug in the study and the last administration of the drug in the previous clinical study or more than 5 half-lives of the drug in the study)
- An active infection requiring systemic therapy.
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 |
|---|---|---|
| Cadonilimabrecurrent or metastatic cervical cancer in the first, second or third lines Systematic treatment | Drug | Cadonilimab-treated Recurrent or Metastatic Cervical Cancer |
Primary outcome
Objective response rate (ORR)
Time frame: from the first drug administration up to two years
ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
4 secondary outcomes
Disease control rate (DCR)
Time frame: from the first drug administration up to two years
progression-free survival (PFS)
Time frame: from the first drug administration up to two years
overall survival (OS)
Time frame: from the first drug administration up to two years
Incidence and severity of adverse events(AEs)
Time frame: from the first drug administration up to two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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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.
Gang Chen contact
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent or Metastatic Cervical Cancer, run by Gang Chen (101199).
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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ding Ma (86-027-8362681, dma@tjh.tjmu.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: from the first drug administration up to two years). 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 4 Dec 2023.