A Prospective Real-world Study of Cadonilimab in Patients With Recurrent or Metastatic Cervical Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-90
SponsorGang Chen (101199)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Cadonilimab
Drugrecurrent or metastatic cervical cancer in the first, second or third lines Systematic treatment
Treatment groups
670 Participants
are divided into 1 treatment groupGroup A: Cadonilimab-treated Recurrent or Metastatic Cervical Cancer1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
from the first drug administration up to two yearsSecondary outcomes
1
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.
Time frame
from the first drug administration up to two years2
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.
Time frame
from the first drug administration up to two years3
overall survival (OS)
Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause.
Time frame
from the first drug administration up to two years4
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.
Time frame
from the first drug administration up to two yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gang Chen (101199)
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: