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Camrelizumab Combined With Apatinib for Recurrent Resistant GTN: a Phase 2 Single-arm Prospective Study (GTN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047017
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
xiang yang, Peking Union Medical College Hospital

Brief Summary:
This study is intend to improve the progression free survival in treatment of camrelizumab combined with apatinib in platinum-resistant recurrent patients.

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Disease Drug: Apatinib Drug: Camrelizumab Phase 2

Detailed Description:
Apatinib is an oral small-molecule tyrosine kinase inhibitor that selectively binds to and inhibits VEGF receptor 2. Novel immunotherapy using the immune checkpoint inhibitors such as anti-PD-1 antibody has received much attention. Camrelizumab as one of the anti-PD-1 drug have impressive clinical activity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Camrelizumab Combined With Apatinib for Recurrent Resistant Gestational Trophoblastic Neoplasia: a Phase 2, Single-arm, Prospective Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: Test group
Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. Apatinib :250 mg po qd
Drug: Apatinib
250mg, po, qd

Drug: Camrelizumab
200mg, q2w




Primary Outcome Measures :
  1. PFS(progression free survival) [ Time Frame: Up to two years ]
    the time from randomization until objective tumor progression or death


Secondary Outcome Measures :
  1. ORR(objective response rate) [ Time Frame: Up to two years ]
    the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

  2. CBR(clinical benefit rate) [ Time Frame: Up to two years ]
    CBR=CR+PR+SD≥24 weeks

  3. DoR(duration of response) [ Time Frame: Up to two years ]
    the time from CR/PR until objective tumor progression or death

  4. OS(overall survival) [ Time Frame: Up to two years ]
    the time from randomization until death from any cause and is measured in the intent-to-treat population

  5. Safety as measured by adverse events [ Time Frame: Up to two years ]
    Number of Participants with treatment related Adverse Events as Assessed by CTCAE



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with recurrent resistant GTN previously received twice or more combination chemotherapy before enrolment;
  2. In the 20000 FIGO staging and classification, a risk score of 7 and above 7 (Considered high risk) or resistant recurrent placental site trophoblastic tumor or resistant recurrent epithelial trophoblastic tumor;
  3. Aged 18-70 years;
  4. An Eastern Cooperative Oncology Group performance status of 0-2;
  5. Woman with abnormal human Chorionic Gonadotropin (hCG) or According to the solid tumor efficacy evaluation standard (RECIST1.1), at least one measurable lesion,
  6. Expected survival ≥ 4 months;
  7. The function of vital organs meets the following requirements: Hemoglobin≥80g/L; Absolute neutrophil count≥1.5*109/L;Platelets≥100

    *109/L; Creatinine≤1.5 times ULN; Urea nitrogen≤2.5 times ULN; Total Bilirubin≤ULN; ALT and AST ≤ 2.5 times ULN; Albumin≥25g/L; TSH≤ULN(if TSH is abnormal, normal T3 and T4 also can acceptable)

  8. Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration.
  9. The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form

Exclusion Criteria:

  1. Previously exposed to other anti-angiogenic small-molecule TKI drugs, such as pazopanib, sorafenib, regorafenib, cilnitraz, etc. or anti-angiogenic mAbs such as bevacizumab ; or had used an anti-PD-1 antibody, an anti-CTLA-4 antibody, TCR-T, CAR-T and other immune therapy; or 4 weeks before the first administration participated in any other clinical trials of anticancer drugs; or before the first dose Live attenuated vaccines are accepted within 4 weeks or during the study period.
  2. Other malignant tumors have occurred in the past 3 years..
  3. Immunosuppressive drugs used within 14 days prior to the first use of SHR-1210, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie, no more than 10 mg/day of turmeric or equivalent drug physiological dose) Other corticosteroids).
  4. Late-stage patients with symptomatic, disseminated to visceral, short-term risk of life-threatening complications (including uncontrolled large amounts of exudate [thoracic, pericardium, abdominal cavity], pulmonary lymphangitis, and more than 30% liver involvement patients).
  5. Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function; subjects with vitiligo or complete remission asthma in childhood and without any intervention, all above can be included; asthma requiring medical intervention for bronchodilators should be excluded).
  6. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal medical treatment.
  7. Grade II or higher myocardial ischemia, myocardial infarction or poor control arrhythmia (including male with QTc interval ≥ 450ms, or female with QTc interval≥ 470ms). According to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%; myocardial infarction occurred within 6 months before enrollment, New York Heart Association Level II or above failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, pericardial disease with clinically significant, or electrocardiogram suggesting acute ischemia or abnormal active conduction system.
  8. Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
  9. Half of a teaspoons (2.5 ml) or more hemoptysis was found within the first 2 months or there were significant clinical bleeding symptoms or clearly propensity bleeding within 3 months before participant in the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above in baseline or vasculitis; artery or venous thrombosis events within 6 months prior to the study, such as cerebrovascular accidents (Including transient ischemic attacks, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism.
  10. Severe infections within 4 weeks prior to accept medication (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever during screening/first administration >38.5 °C
  11. Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders.
  12. Major surgical procedures were performed within 4 weeks before the first administration. Or open wounds or fractures.
  13. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or sinus or perforation of empty organs within 6 months.
  14. Routine urine test indicated that urinary protein (++) or more, confirmed urinary protein (>1.0 g) within 24 hours.
  15. Patients with a history of allergy may be potentially allergic or intolerant to Apatinib and biological agents SHR-1210.
  16. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA (> 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of the analysis method) or co-infection with hepatitis B and hepatitis C.
  17. There is any situation that may damage the subject or cause the subject to fail to meet or implement the research requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047017


Contacts
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Contact: Yang Xiang 010-69156068 XiangY@pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Yang Xiang    01069156068    XiangY@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: xiang yang, Chief, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04047017     History of Changes
Other Study ID Numbers: OBU-GTN-MUL-IIT-SHR1210-APA
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gestational Trophoblastic Disease
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Pregnancy Complications, Neoplastic
Pregnancy Complications
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action