SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
ConditionCervical Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
This study is a randomized, open-label, controlled, multicenter phase Ⅲ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy and PD-1/L1 inhibitor therapy
Eligibility criteria
Qualifiers
1. Patients aged 18-75 years (inclusive);
2. Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent;
3. Subject must have received a platinum-based chemotherapy with anti-PD-(L)1 agent and if was received administered in the adjuvant/neoadjuvant setting subject must have progressed during treatment or within 6 months of treatment completion；received no more than 2 prior systemic therapy in the metastatic/recurrent setting; must have experienced radiographic progression during or after the last treatment regimen;
4. An archival tumor tissue sample or a fresh tissue sample should be provided;
Disqualifiers
1. Has other histologies not mentioned as part of the inclusion criteria 2;
2. Active central nervous system metastases or leptomeningeal metastasis;
3. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk)；
5. Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization;with major surgery within 4 weeks prior to randomization;
Trial design
Treatments tested in this trial
- SYS6002
- Investigator's Choice of Chemotherapy
Treatment groups
412 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov