Status:
WITHDRAWN
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of HLX10(Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) plus chemotherapy compared to the efficacy and safety of placebo ...
Eligibility Criteria
Inclusion
- Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)
- CPS≥1
- Has measurable disease per RECIST 1.1 as assessed by IRRC
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
- Has adequate organ function
Exclusion
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has received prior therapy with an anti-PD-1, anti-PD-L1 or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4）
Key Trial Info
Start Date :
September 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04806945
Start Date
September 30 2022
End Date
October 30 2024
Last Update
May 5 2022
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China