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NCT Number: NCT04680988

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

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.

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Key information

Conditions

Recurrent or Metastatic Cervical Cancer Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

SHR-1210

Drug

SHR-1210 intravenously every 3 weeks

Other names: Camrelizumab

SHR-1020

Drug

SHR-1020 Orally once daily

Other names: Famitinib

Physician's choice chemotherapy

Drug

Investigators will declare one of the following regimens:Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection

Other names: Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection

Primary outcomes

  1. Objective Response Rate (ORR) assessed by Blinded Independent Central Review in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)

    Time frame: Up to approximately 2 years

    Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.

Secondary outcomes

  1. Progression free survival (PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)

    Time frame: Up to approximately 2 years

    PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first.

  2. Overall survival (OS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)

    Time frame: Up to approximately 2 years

    OS is the time interval from randomization to death due to any reason or lost of follow-up.

  3. Objective Response Rate (ORR) assessed by investigator in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)

    Time frame: Up to approximately 2 years

    Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.

  4. Disease control rate (DCR)，recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria

    Time frame: Up to approximately 2 years

    Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions), PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or SD (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.

  5. Duration of response (DoR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.

    Time frame: Up to approximately 2 years

    For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death from any cause, whichever came first. The DOR per RECIST 1.1 as assessed by Investigator will be presented.

  6. Time to response (TTR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.

    Time frame: Up to approximately 2 years

    Defined as the time from randomization to the first objective tumor response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters)) observed for patients who achieved a CR or PR.

  7. Time to treatment failure (TTF)，in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.

    Time frame: Up to approximately 2 years

    Defined as the time from randomization to the end of treatment or death from any cause, whichever came first.

  8. Adverse Events (AEs)

    Time frame: from the first drug administration to within 90 days for the last treatment dose

  9. Tolerance

    Time frame: from the first drug administration to within 90 days for the last treatment dose

    To calculate the proportion of dose interruption, dose reduction or dose termination because of drug-related toxicity

  10. Characteristic of Anti drug antibody

    Time frame: from the first drug administration to within 90 days for the last treatment dose

    Defined as ratio of ADAs of SHR-1210 during the treatment compared to baseline.

  11. Peak Serum Concentration of SHR-1210

    Time frame: from the first drug administration to within 90 days for the last treatment dose

    Defined as peak serum concentration of SHR-1210 during the treatment compared to baseline

  12. Peak Plasma Concentration of famitinib

    Time frame: from the first drug administration to within 90 days for the last treatment dose

    Defined as peak plasma concentration of famitinib during the treatment compared to baseline

  13. Area under the Serum Concentration versus Time Curve of SHR-1210

    Time frame: from the first drug administration to within 90 days for the last treatment dose

    Defined as area under the serum concentration versus time curve of SHR-1210 during the treatment compared to baseline

  14. Area under the Plasma Concentration versus Time Curve of famitinib

    Time frame: from the first drug administration to within 90 days for the last treatment dose

    Defined as area under the plasma concentration versus time curve of famitinib during the treatment compared to baseline

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2020
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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