Overview

Camrelizumab /Apatinib for Recurrent Platinum-resistant Ovarian Cancer

Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College Hospital
Treatments:
Apatinib
Criteria
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.