This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/L1 inhibitor therapy.
Voluntary participation and written informed consent.
≥18 years;
ECOG performance status score of 0 or 1.
Expected survival of more than 3 months.
Tumors with histologic components other than squamous-cell carcinoma and adenocarcinoma.
Other-malignancy diagnosed within 3 years prior to randomization.
Active central nervous system metastases.
Baseline imaging showing tumor invasion, compression of, or arising from vital organs.
Parallel
JSKN033
DrugJSKN033 should be administered subcutaneously
Docetaxel
DrugDocetaxel
Topotecan
DrugTopotecan
Gemcitabine (GEM)
DrugGemcitabine
Pemetrexed
DrugPemetrexed
Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Overall Survival (OS)
OS was defined as the time from randomization until the date of death from any cause
Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
PFS evaluated by the Investigator as per RECIST 1.1
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
