AzTrials
AzTrials

Recurrent or Metastatic Cervical CancerPhase 2NCT04680988

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

A Phase 2 study testing SHR-1210, SHR-1020 and Physician's choice chemotherapy in people with Recurrent or Metastatic Cervical Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Recurrent or Metastatic Cervical Cancer
What is being tested?
SHR-1210, SHR-1020 and Physician's choice chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteChina
Study dates
5 Apr 2021to 7 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

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

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.

Read the 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).

Being tested
SHR-1210, SHR-1020, Physician's choice chemotherapy
Medical subject headings
Recurrence, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    Also called Camrelizumab

    SHR-1210 intravenously every 3 weeks

  • SHR-1020Drug

    Also called Famitinib

    SHR-1020 Orally once daily

  • Physician's choice chemotherapyDrug

    Also called Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection

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

Study groups in NCT04680988
Study groupRoleWhat they receive
Doublet ArmExperimentalSHR-1210+SHR-1020
Receives: Drug: SHR-1210; Drug: SHR-1020
Single ArmExperimentalSHR-1210
Receives: Drug: SHR-1210
Physician's choice chemotherapyActive comparatorAlbumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection
Receives: Drug: Physician's choice chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to approximately 2 years

Secondary outcomes (14)

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

    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.

    Measured: Up to approximately 2 years

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

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

    Measured: Up to approximately 2 years

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

    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.

    Measured: Up to approximately 2 years

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

    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.

    Measured: Up to approximately 2 years

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

    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.

    Measured: Up to approximately 2 years

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

    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.

    Measured: Up to approximately 2 years

  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.

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

    Measured: Up to approximately 2 years

  8. Adverse Events (AEs)

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

  9. Tolerance

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

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

  10. Characteristic of Anti drug antibody

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

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

  11. Peak Serum Concentration of SHR-1210

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

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

  12. Peak Plasma Concentration of famitinib

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

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

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start5 Apr 2021
  3. Primary completion7 Jul 2025
  4. Study completion7 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04680988
Sponsor's protocol ID
SHR-1210-II-217
Status last verified
Aug 2025
First submitted
7 Dec 2020
Last updated
5 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xia L, Zhang K, Tang Y, Zhang G, Wang D, Lou H, Liu N, Zhang H, Chen H, Wang K, Wei S, Wang L, Gao K, Li G, Zhang H, Hu Y, Zhao W, Zhang Y, Zhu H, Lin A, Miao J, Yu G, Hua K, Tang L, Liu Z, Zhang B, Li H, Zheng M, Wang X, Li F, Yang X, Zhou H, Xia B, Zhou X, Wang Y, Wang Q, Wu X. Camrelizumab Plus Famitinib versus Camrelizumab Alone and Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer: A Randomized, Phase II Study. J Clin Oncol. 2025 Aug 20;43(24):2720-2733. doi: 10.1200/JCO-24-02495. Epub 2025 Jun 25.

    PubMed 40561369

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210, SHR-1020 and Physician's choice chemotherapy in people with Recurrent or Metastatic Cervical Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04680988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in