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An observational study of carilizumab in the treatment of platinum-resistant/platinum-sensitive recurrent ovarian cancer

An observational study of carilizumab in the treatment of platinum-resistant/platinum-sensitive recurrent ovarian cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049892
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-08-11
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

Camrelizumab treated patients:None

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG PS: 0-2 points; 3. Patients with advanced ovarian cancer diagnosed by histopathology or cytology; 4. Patients with ovarian cancer diagnosed by histology/cytology and imaging examination and recurrence of ovarian cancer with a measurable lesion or tumor marker CA125>35U/L according to RECIST 1.1 criteria; 5. Baseline blood routine and biochemical indicators meet the following standards: (1) Hemoglobin>=90g/L (2) Absolute neutrophil count (ANC) >=1.5x10^9/L (3) Platelets>=80x10^9/L (4) ALT, AST=45 ml/min (Cockcroft-Gault formula); 6. No blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors; 7. Expected survival period >= 3 months; 8. Adequate organ function; 9. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; 10. The observed patients voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 11. Patients who, in the physician's opinion, may benefit from camrelizumab treatment and who voluntarily receive treatment.

Exclusion criteria

Exclusion criteria: 1. Has been confirmed to be allergic to the study drug and/or its excipients; 2. The observed patient was receiving immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose & GT; 10mg/ day of prednisone or other efficacy hormone) and had been treated with a clinical trial drug or used a clinical trial medical device within the first 4 weeks of continued use within the first 2 weeks of enrollment; 3. Patients with hypertension who cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure & GT; 140 mmHg, diastolic blood pressure > 90 mmHg), with grade I coronary heart disease or above and grade I arrhythmia (including prolonged QTc interval > 450ms in men and > 470ms in women); 4. Patients with grade ? ~ ? cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) 1.5, APTT> 1.5 ULN), with bleeding tendency; Pre-existing genetic or acquired tendencies for bleeding and thrombosis (e.g., hemophilia, clotting disorders, thrombocytopenia, hypersplenism, etc.); 6. Long-term unhealed wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 7. Accompanied by abdominal fistula, gastrointestinal perforation or abdominal abscess; Patients with acute or chronic active hepatitis B or HEPATITIS C, hepatitis B virus (HBV), HEPATITIS B virus (DNA>); 2000 iu/ml; Hepatitis C Virus (HCV) 500 IU/ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody were positive simultaneously. After nucleotide antiviral therapy, if the level is lower than the above criteria, it can be included in the group; 8. Patients with active brain metastases, malignant meningitis, spinal cord compression, or diseases of the brain or pia meninges detected by imaging CT or MRI at the time of screening (patients with brain metastases who have completed treatment 21 days before medication and have stable symptoms can be included, but have no symptoms of intracerebral hemorrhage confirmed by brain MRI, CT or venography evaluation); 9. Imaging (CT or MRI) shows that the distance between the tumor focus and the large vessels is less than or equal to 5 mm, or the lesion has invaded the local large vessels; 10. Pregnant or breastfeeding women; 11. Patients with a history of abuse of psychotropic substances and unable to quit or with mental disorders; 12. Patients with concomitant diseases that, according to the investigator's judgment, seriously endanger patient safety or affect patient completion of the study; 13. Not suitable for inclusion according to the researcher.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
overall survival;disease control rate;

Countries

China

Contacts

Public ContactCheng Linghui

The First Affiliated Hospital of Anhui Medical University

chenglinghui71@163.com+86 13721066591

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026