NCT04680988CompletedPhase 2
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer
A Randomized,Open-label, Multi-Center, Phase II Clinical Trial to Assess the Efficacy and Safety of SHR-1210± SHR-1020 Versus Physician's Choice Chemotherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Patients
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
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 cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 194 (actual)
- First submitted
- 7 Dec 2020
- Start date
- 5 Apr 2021
- Primary completion date
- 7 Jul 2025
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Cervical cancer
- NCT number
- NCT04680988
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 194
- From 5 Apr 2021 to the primary completion date, 7 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has any malignancy \<5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer \>3 years.
- Recived other anticancer therapy 4 weeks before randomization.
Other illness
- Known to have autoimmune disease.
- Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
- With high risk of vaginal bleeding or gastrointestinal perforation.
Lab values
- 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.
Other
- Untreated and/or uncontrolled brain metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.