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Camrelizumab /Apatinib for Recurrent Platinum-resistant Ovarian Cancer

14 de março de 2021 atualizado por: Lingya Pan, Peking Union Medical College Hospital

Camrelizumab Combined With Apatinib for Recurrent Platinum-resistant Ovarian Cancer: a Phase 2 Single-arm Prospective Study

This study is intend to improve the progression-free survial of the recurrent paltinum-resistant ovarian cancer. All the participants will receive camrelizumab combined with apatinib.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Antecipado)

28

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Pan Lingya
  • Número de telefone: 010-69156204
  • E-mail: Panly@pumch.cn

Locais de estudo

      • Beijing, China
        • Recrutamento
        • Peking Union Medical College Hospital
        • Contato:
          • Pan Lingya

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  1. Patients with recurrent -resistant epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer previously received twice or more platinum chemotherapy before enrolment;
  2. Recurrence occurred within 6 months after the last platinum-containing chemotherapy and had experienced at least one platinum-sensitive recurrent in the past.;
  3. Aged 18-70 years;
  4. An Eastern Cooperative Oncology Group performance status of 0-2;
  5. According to the solid tumor efficacy evaluation standard (RECIST1.1) or i RECIST, at least one measurable lesion, with maximum diameter > 1 cm and lymph node metastasis > 1.5 cm, and the target lesion is not suitable for surgical treatment; the target lesion has not received radiotherapy or recurred in the field of radiotherapy.
  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. 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. Primary platinum refractory patients (first platinum-containing chemotherapy with recurrence within 6 months)
  2. 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.
  3. Target lesions observed received radiotherapy
  4. Other malignant tumors have occurred in the past 3 years..
  5. 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).
  6. 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).
  7. 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).

8 Metastatic foci of the central nervous system have significant symptoms, such as headache, cerebral edema and blurred vision 9. CT or MRI showed tumor lesion 5mm away from the great blood vessel, or tumor invading the local great blood vessel, or accompanied by tumor thrombus formation of the great vein (inferior vena cava of iliac vessel, superior vena cava of pulmonary static vein) 10. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal medical treatment.

11. 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.

12, 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.

13. 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.

14. 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 15. Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders.

16. Major surgical procedures were performed within 4 weeks before the first administration. Or open wounds or fractures.

17. 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.

18. Routine urine test indicated that urinary protein (++) or more, confirmed urinary protein (>1.0 g) within 24 hours.

19. Patients with a history of allergy may be potentially allergic or intolerant to Apatinib and biological agents SHR-1210.

20. 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.

21. There is any situation that may damage the subject or cause the subject to fail to meet or implement the research requirements.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Test group
Camrelizumab (SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. Apatinib :250 mg po qd
Anticancer T-cell activity is regulated by multiple suppressive mechanisms, including tumour-expressed programmed cell death ligand 1 (PD-L1) signalling to the T-cell inhibitory receptor (programmed death protein 1 [PD-1]). Monoclonal antibodies like SHR-1210 that can block this pathway.
Apatinib is an oral small-molecule tyrosine kinase inhibitor that selectively binds to and inhibits VEGF receptor 2.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Objective Response Rate
Prazo: Up to two years
The proportion of participants with tumor size reduction of a predefined amount and for a minimum time period.
Up to two years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression Free Survival
Prazo: Up to two years
The time from treatment until objective tumor progression or death, whichever occurs first.
Up to two years
Disease Control Rate
Prazo: Up to two years
The proportion of patients with complete response, partial response or keep stable diease after accept treatment.
Up to two years
Duration of Response (DoR)
Prazo: Up to two years
The time from firstly complete response or partly response to progressive disease.
Up to two years
Assessment of safety
Prazo: Up to two years
The quantity and degree of adverse event and serious adverse event from
Up to two years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Pan lingya, Peking Union Medical College Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de outubro de 2019

Conclusão Primária (Antecipado)

30 de junho de 2021

Conclusão do estudo (Antecipado)

30 de junho de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

13 de agosto de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de agosto de 2019

Primeira postagem (Real)

28 de agosto de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de março de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de março de 2021

Última verificação

1 de março de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Camrelizumab (SHR-1210)

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