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CompletedNCT03816553Updated Apr 11, 2023

SHR-1210 in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer

A Phase 2 interventional study of SHR-1210 and Apatinib in Recurrent Cervical Carcinoma and Metastatic Cervical Cancer, sponsored by Sun Yat-sen University. Completed at 3 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

The purpose of this study is to explore the efficacy and safety of SHR-1210 in combination with apatinib in treating patients with metastatic, persistent, or recurrent cervical cancer.

Read the detailed description

SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) selectively inhibits Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2). Patients with metastatic, persistent, or recurrent cervical cancer who failed to first-line chemotherapy +/- bevacizumab will received SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks and apatinib 250mg orally once daily. The efficacy and safety will be observed.

02

Conditions studied

  • Recurrent Cervical Carcinoma
  • Metastatic Cervical Cancer
03

In context

Uterine Cervical Neoplasms

1,928 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.

This study's enrollment of 45 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,681 studies on the registry; 610 are open to participants now.

Browse Sun Yat-sen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients must have metastatic, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy;
  2. Age ≥ 18 years and ≤ 70 years;
  3. Patients must have measurable disease per RECIST 1.1; measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥ 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI),; a lymph node must be ≥ 15 mm in short axis. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  5. Life expectancy exceeds 3 months;

  6. Patients must have had at least one prior systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix.

    Note: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix; adjuvant therapy includes cisplatin given concurrent with primary radiation therapy (CCRT) and adjuvant chemotherapy given following the completion of concurrent chemotherapy and radiation therapy

  7. Patients must have adequate organ function

    • Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L
    • Platelet count ≥ 80 × 10\^9/L
    • Hemoglobin ≥ 90 g/L
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (however, patients with known liver metastasis who have AST or ALT level ≤ 5 × ULN may be enrolled)
    • Creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula)
    • Baseline albumin ≥ 28 g/L
    • Thyroid-stimulating hormone (TSH) levels ≤ 1 × ULN (however, patients with free Triiodothyronine [FT3] or free Thyroxine [FT4] levels ≤ 1 × ULN may be enrolled)
  8. Written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Histopathologic diagnoses of tumors other than squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma.
  2. Participated in other clinical trials, or finish other clinical trials within 4 weeks.
  3. Prior exposure to immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies, or prior exposure to apatinib.
  4. Known history of hypersensitivity to any components of the SHR-1210 formulation, or other monoclonal antibody.
  5. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
  6. Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
  7. Clinically significant cardiovascular diseases, including but not limited to congestive heart failure (New York heart association (NYHA) class > 2), unstable or severe angina, severe acute myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia which need medical intervention, or QT interval male ≥ 450 ms, female ≥ 470 ms.
  8. Arterial thrombus or phlebothrombosis within 6 months.
  9. Hypertension that can not be well controlled through antihypertensive drugs (systolic pressure ≥ 140 mm Hg and/or diastolic pressure ≥ 90 mm Hg)
  10. Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g.
  11. Coagulation abnormalities (INR>2.0、PT>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
  12. Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events (except for alopecia) due to a previously administered agent.
  13. Has known active central nervous system metastases.
  14. Patients with a prior invasive malignancy who have had any evidence of disease within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  15. Has an active infection requiring systemic therapy.
  16. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease.
  17. Hepatitis B virus (HBV) >2000 IU/ml or DNA ≥ 1×10\^4/ml; or hepatitis C virus (HCV) RNA ≥ 1×10\^3/ml).
  18. Has received a live vaccine within 4 weeks prior to the first dose of trial treatment. Note: Injection of inactivated viral vaccines against seasonal influenza are allowed.
  19. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    SHR-1210 + Apatinib

    Participants receive SHR-1210 200mg (3mg/kg for underweight patients) intravenously every 2 weeks and apatinib 250mg orally once daily until disease progression or unacceptable toxicity

    Drug: SHR-1210 · Drug: Apatinib

Interventions

  • DrugSHR-1210

    SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg (3mg/kg for underweight patients).

    Also known as: Camrelizumab

  • DrugApatinib

    Apatinib will be administered 250mg orally, once daily until progression.

    Also known as: Apatinib Mesylate

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Time frame: Up to approximately 12 months

Secondary outcomes

  1. Progression-free Survival (PFS)

    Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause

    Time frame: Up to approximately 24 months

  2. Overall survival (OS)

    Overall survival is defined as the duration from date of enrollment to the date of death from any cause.

    Time frame: Up to approximately 24 months

  3. 6-month PFS rate

    The rate of 6-month PFS

    Time frame: From date of enrollment up to 6 months

  4. 9-month OS rate

    The rate of 9-month OS

    Time frame: From date of enrollment up to 9 months

  5. Duration of Response (DCR)

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.

    Time frame: Up to approximately 24 months

  6. Duration of Response (DOR)

    DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Time frame: Up to approximately 24 months

  7. Incidence of Adverse Events (AEs) in the treatment of SHR1210 in combination with apatinib

    Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.

    Time frame: Up to approximately 24 months

Other outcomes

  1. Impact of the treatment on Quality of Life (QOL) measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)

    The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. The score ranges 0-116 with a large score suggesting better QOL.

    Time frame: Baseline, every other cycle (each cycle is 28 days) and up to approximately 24 months

  2. Pain assessed by Brief Pain Inventory (BPI)

    Single item from the BPI assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.

    Time frame: Baseline, every other cycle (each cycle is 28 days) and up to approximately 24 months

  3. PD-L1 expression on tumor and immune cells

    The efficacy of the combination of SHR-1210 and apatinib as measured by objective response, will be described in patients according to PD-L1 positive and PD-L1 negative.

    Time frame: Up to approximately 24 months

  4. Tumor Mutation Burden (TMB)

    The impact of TMB on efficacy of the combination of SHR-1210 and apatinib will be explored.

    Time frame: Up to approximately 24 months

07

Study locations

3 sites
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
  • Guangzhou Panyu Central Hospital
    Guangzhou, Guangdong 511400, China
  • The First affiliated Hospital of Sun Yat-sen University
    Guanzhou, Guangdong 510080, China
08

References and documents

Publications

  • Wang Y, Lai Y, Peng H, Yan S, Liu Z, Tong C, Huang X. Multiparametric immune profiling of advanced cervical cancer to predict response to programmed death-1 inhibitor combination therapy: an exploratory study of the CLAP trial. Clin Transl Oncol. 2023 Jan;25(1):256-268. doi: 10.1007/s12094-022-02945-1. Epub 2022 Sep 17. PubMed 36115931 ↗
  • Huang X, He M, Peng H, Tong C, Liu Z, Zhang X, Shao Y, Zhu D, Zhang J, Yin JC, Yang F, Lan C. Genomic profiling of advanced cervical cancer to predict response to programmed death-1 inhibitor combination therapy: a secondary analysis of the CLAP trial. J Immunother Cancer. 2021 May;9(5):e002223. doi: 10.1136/jitc-2020-002223. PubMed 34011535 ↗
  • Lan C, Shen J, Wang Y, Li J, Liu Z, He M, Cao X, Ling J, Huang J, Zheng M, Zou G, Yan H, Liu Q, Yang F, Wei W, Deng Y, Xiong Y, Huang X. Camrelizumab Plus Apatinib in Patients With Advanced Cervical Cancer (CLAP): A Multicenter, Open-Label, Single-Arm, Phase II Trial. J Clin Oncol. 2020 Dec 1;38(34):4095-4106. doi: 10.1200/JCO.20.01920. Epub 2020 Oct 14. PubMed 33052760 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03816553
Lead sponsor
Sun Yat-sen University
Responsible party
Xin Huang (Professor, Sun Yat-sen University) — Principal investigator
First posted
Jan 25, 2019
Start date
Jan 19, 2019
Primary completion
Apr 30, 2020
Completion
Aug 31, 2022
Last update
Apr 11, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Camrelizumab · Apatinib

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