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Spots Global Cancer Trial Database for A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer

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Trial Identification

Brief Title: A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer

Official Title: 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

Study ID: NCT04680988

Study Description

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 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.

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 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.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210;2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice chemotherapy).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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