- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04068974
Camrelizumab /Apatinib for Recurrent Platinum-resistant Ovarian Cancer
Camrelizumab Combined With Apatinib for Recurrent Platinum-resistant Ovarian Cancer: a Phase 2 Single-arm Prospective Study
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Beijing, Cina
- Reclutamento
- Peking Union Medical College Hospital
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Contatto:
- Pan Lingya
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients with recurrent -resistant epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer previously received twice or more platinum chemotherapy before enrolment;
- Recurrence occurred within 6 months after the last platinum-containing chemotherapy and had experienced at least one platinum-sensitive recurrent in the past.;
- Aged 18-70 years;
- An Eastern Cooperative Oncology Group performance status of 0-2;
- 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.
- Expected survival ≥ 4 months;
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)
- 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:
- Primary platinum refractory patients (first platinum-containing chemotherapy with recurrence within 6 months)
- 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.
- Target lesions observed received radiotherapy
- Other malignant tumors have occurred in the past 3 years..
- 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).
- 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).
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Test group
Camrelizumab (SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.
Apatinib :250 mg po qd
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Objective Response Rate
Lasso di tempo: Up to two years
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The proportion of participants with tumor size reduction of a predefined amount and for a minimum time period.
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Up to two years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Progression Free Survival
Lasso di tempo: Up to two years
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The time from treatment until objective tumor progression or death, whichever occurs first.
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Up to two years
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Disease Control Rate
Lasso di tempo: Up to two years
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The proportion of patients with complete response, partial response or keep stable diease after accept treatment.
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Up to two years
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Duration of Response (DoR)
Lasso di tempo: Up to two years
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The time from firstly complete response or partly response to progressive disease.
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Up to two years
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Assessment of safety
Lasso di tempo: Up to two years
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The quantity and degree of adverse event and serious adverse event from
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Up to two years
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Pan lingya, Peking Union Medical College Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie genitali, femmina
- Malattie del sistema endocrino
- Attributi della malattia
- Malattie ovariche
- Malattie annessiali
- Disturbi gonadici
- Neoplasie delle ghiandole endocrine
- Ricorrenza
- Neoplasie ovariche
- Carcinoma, epiteliale ovarico
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Apatinib
Altri numeri di identificazione dello studio
- OBU-OvaC-IIT-SHR1210-APA
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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