Camrelizumab /Apatinib for Recurrent Platinum-resistant Ovarian Cancer

Last updated: March 14, 2021
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cysts

Treatment

N/A

Clinical Study ID

NCT04068974
OBU-OvaC-IIT-SHR1210-APA
  • Ages 18-70
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with recurrent -resistant epithelial ovarian cancer, fallopian tube cancerand primary peritoneal cancer previously received twice or more platinum chemotherapybefore enrolment;
  2. Recurrence occurred within 6 months after the last platinum-containing chemotherapyand 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, atleast 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 targetlesion 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 andT4 also can acceptable)
  8. The subject should be aware of the purpose of the study and the operations required bythe study and volunteer to participate in the study before sign the informed consentform.

Exclusion

Exclusion Criteria:

  1. Primary platinum refractory patients (first platinum-containing chemotherapy withrecurrence within 6 months)
  2. Previously exposed to other anti-angiogenic small-molecule TKI drugs, such aspazopanib, sorafenib, regorafenib, cilnitraz, etc. or anti-angiogenic mAbs such asbevacizumab ; or had used an anti-PD-1 antibody, an anti-CTLA-4 antibody, TCR-T, CAR-Tand other immune therapy; or 4 weeks before the first administration participated inany other clinical trials of anticancer drugs; or before the first dose Liveattenuated 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 steroidhormones (ie, no more than 10 mg/day of turmeric or equivalent drug physiologicaldose) Other corticosteroids).
  6. Late-stage patients with symptomatic, disseminated to visceral, short-term risk oflife-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 notlimited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreasedthyroid function; subjects with vitiligo or complete remission asthma in childhood andwithout any intervention, all above can be included; asthma requiring medicalintervention for bronchodilators should be excluded).

8 Metastatic foci of the central nervous system have significant symptoms, such asheadache, cerebral edema and blurred vision 9. CT or MRI showed tumor lesion 5mm away fromthe great blood vessel, or tumor invading the local great blood vessel, or accompanied bytumor thrombus formation of the great vein (inferior vena cava of iliac vessel, superiorvena cava of pulmonary static vein) 10. Uncontrollable hypertension (systolic bloodpressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal medicaltreatment. 11. Grade II or higher myocardial ischemia, myocardial infarction or poor controlarrhythmia (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 Dopplerultrasound examination showed left ventricular ejection fraction (LVEF) <50%; myocardialinfarction occurred within 6 months before enrollment, New York Heart Association Level IIor above failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia,pericardial disease with clinically significant, or electrocardiogram suggesting acuteischemia 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 orthere were significant clinical bleeding symptoms or clearly propensity bleeding within 3months before participant in the study, such as gastrointestinal bleeding, hemorrhagicgastric ulcer, fecal occult blood ++ or above in baseline or vasculitis; artery or venousthrombosis events within 6 months prior to the study, such as cerebrovascular accidents (Including transient ischemic attacks, cerebral hemorrhage, cerebral infarction, deep veinthrombosis and pulmonary embolism. 14. Severe infections within 4 weeks prior to accept medication (eg, intravenous infusionof antibiotics, antifungal or antiviral drugs), or unexplained fever during screening/firstadministration >38.5 °C 15. Those who have a history of psychotropic drug abuse and areunable to quit or have mental disorders. 16. Major surgical procedures were performed within 4 weeks before the firstadministration. 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 urinaryprotein (>1.0 g) within 24 hours. 19. Patients with a history of allergy may be potentially allergic or intolerant toApatinib and biological agents SHR-1210. 20. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiencysyndrome (AIDS), active hepatitis B (HBV DNA (> 500 IU/ml), hepatitis C (hepatitis Cantibody positive, and HCV-RNA higher than the lower limit of the analysis method) orco-infection with hepatitis B and hepatitis C. 21. There is any situation that may damage the subject or cause the subject to fail to meetor implement the research requirements.

Study Design

Total Participants: 28
Study Start date:
October 28, 2019
Estimated Completion Date:
June 30, 2022

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

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