Status:
COMPLETED
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Recurrent or Metastatic Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical ...
Detailed Description
This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical ...
Eligibility Criteria
Inclusion
- Voluntarily agree to participate by giving written informed consent.
- Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
- The patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease.
- Patients must provide a fresh biopsy. If not, sufficient and adequate tumor tissue sample from the most recent biopsy of a tumor lesion will be required for PD-L1 expression.
- Has measurable lesion on imaging based on RECIST version 1.1.
- Have a life expectancy of at least 3 months.
- ECOG performance status 0-1.
- If childbearing potential, female patients must be willing to use at least 1 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study treatment.
Exclusion
- Has any malignancy \<5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer \>3 years.
- Has received prior therapy with: anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies; Famitinib; patient is allergic to monoclonal antibody.
- Known to have autoimmune disease.
- Recived other anticancer therapy 4 weeks before randomization.
- Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
- Untreated and/or uncontrolled brain metastases.
- With high risk of vaginal bleeding or gastrointestinal perforation.
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2025
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT04680988
Start Date
April 5 2021
End Date
July 7 2025
Last Update
August 5 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000