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Camrelizumab Combined With Apatinib in the Treatment of Epithelial Ovarian Cancer

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: NCT04507750
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Jing Liang, Qianfoshan Hospital

Brief Summary:
The aim of this study is to explore the effectiveness and safety of camrelizumab combined with apatinib mesylate in the treatment of relapsed platinum-resistant epithelial ovarian cancer

Condition or disease Intervention/treatment Phase
Immune Checkpoint Inhibition Drug: Camrelizumab Not Applicable

Detailed Description:
The anti-PD-1 drug camrelizumab combined with apatinib mesylate was used to treat relapsed platinum-resistant epithelial ovarian cancer, and the effectiveness and safety of the treatment plan was evaluated by objective remission rate, progression-free survival, and major safety indicators , so as to provide patients a more beneficial treatment plan.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Prospective Clinical Study of Camrelizumab Combined With Apatinib Mesylate in the Treatment of Relapsed Platinum-resistant Epithelial Ovarian Cancer
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: camrelizumab+apatinib mesylate
Carmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day.
Drug: Camrelizumab
Carmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day.
Other Name: apatinib mesylate




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: within 1 year ]
    the proportion of patients with tumor size reduction of a predefined amount


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: within 1 year ]
    the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

  2. Disease Control Rate [ Time Frame: within 1 year ]
    Refers to the percentage of confirmed complete remission, partial remission and stable disease (≥ 8 weeks) among patients with evaluable efficacy.

  3. drug safety [ Time Frame: within 1 year ]
    Incidence of test drug relative adverse events,Incidence of serious adverse events

  4. 6 months and 12 months overall survival [ Time Frame: within 2 year ]
    It is the percentage of people in a study or treatment group still alive for a given period of time after diagnosis



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age: 18 to 80 years old;

    2. Histologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer;

    3. Have received at least two lines of systemic chemotherapy;

    4. Platinum resistance (disease progression occurs within 6 months after the last platinum-containing chemotherapy Development) or platinum refractory (disease progression during platinum-containing chemotherapy), ovarian cancer,Fallopian tube cancer, primary peritoneal cancer;

    5. There are measurable lesions (according to RECIST 1.1 standard tumor lesion CT scan long diameter≥10mm, CT scan of lymph node lesions (short diameter≥ 10mm);

    6. ECOG score: 0-1 points;

    7. Estimated survival period ≥ 3 months;

    8. The main organs function well, and the inspection indicators meet the following requirements:Routine blood examination: hemoglobin ≥90 g/L (no blood transfusion within 14 days); neutrophil count ≥1.5×109/L; platelet count ≥80×109/L; biochemical examination: total bilirubin ≤1.5×ULN ( Upper limit of normal); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT or AST ≤ 5×ULN; endogenous creatinine clearance ≥ 50 ml/min (Cockcroft -Gault formula);

    9. The main organs are functioning normally, no blood transfusion or blood products within 14 days;

    10. Subjects of childbearing age must agree to take effective contraceptive measures during the trial;Age women's serum or urine pregnancy test must be negative; non-lactating patients;

    11. Subjects voluntarily join the study and sign an informed consent form, with good compliance and matchingClose follow-up.

Exclusion Criteria:

  • 1. The subject has any active autoimmune disease or a history of autoimmune disease;

    2. Severe allergic reaction to other monoclonal antibodies;

    3. Suffer from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease;

    4. The subject has previously received anti-PD-1, anti-PD-L1, anti-CD137 or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies (including ipilimumab or any other specific targeting T cell Co-stimulation or checkpoint pathway antibodies or drugs) treatment;

    5. Pregnant or breastfeeding women;

    6. Patients who have used anti-angiogenesis therapy in the past, including bevacizumab, apatinib, or anlotinib;

    7. Participated in other drug clinical trials within three months;

    8. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, ulcerative colitis and intestinal obstruction, etc.);

    9. Any bleeding event with a severity level of CTCAE4.0 or higher in the 4 weeks before screening;

    10. Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening;

    11. Patients with hypertension who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg); people with a history of unstable angina; a new diagnosis of angina within 3 months before screening Patients or myocardial infarction events occurred within 6 months before screening; Arrhythmia (including QTcF) requires long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ Grade II cardiac insufficiency;

    12. Long-term unhealed wounds or fractures with incomplete healing;

    13. Have a history of organ transplantation;

    14. Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels and cause fatal bleeding during treatment;

    15. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), those with bleeding tendency (14 days before randomization must meet: INR is normal without using anticoagulants Within the range of values); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; on the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, use for preventive purposes is permitted Low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day);

    16. Arterial/venous thrombosis events occurred in the year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been cured by the investigator ) And pulmonary embolism;

    17. People with a history of psychotropic drug abuse and unable to quit or have mental disorders;

    18. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

    19. Live vaccines may be vaccinated during the study period less than 4 weeks before the study medication;

    20. Other researchers believe that it is not suitable for inclusion.


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): NCT04507750


Contacts
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Contact: Jing Liang, doctor +8618663761275 liangjing0531@163.com

Locations
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China, Shandong
Shandong Provincial Qianfoshan Hospital Recruiting
Jinan, Shandong, China, 250014
Contact: Jing Liang, doctor    +8618663761275    liangjing0531@163.com   
Sponsors and Collaborators
Qianfoshan Hospital
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Liang Jing, doctor Shandong Provincial Qianfoshan Hospital
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Responsible Party: Jing Liang, Professor, Qianfoshan Hospital
ClinicalTrials.gov Identifier: NCT04507750    
Other Study ID Numbers: XYLL-KY-2020-(028)
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
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
Keywords provided by Jing Liang, Qianfoshan Hospital:
camrelizumab
apatinib
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action