recurrent platinum-resistant ovarian cancer
Conditions
Interventions
Case series:fuzuoparib (PARP inhibitor) in combination with apatinib and Camrelizumab (PD-1 inhibitor)
Sponsors
The General Hospital of the People's Liberation Army (PLAGH)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Previous pathological diagnosis of epithelial and high-grade serous ovarian cancer; Preserving previous surgical wax blocks 2. Primary relapse of platinum resistance (not limited to the number of previous platinum-sensitive relapses), the relapse time of the last platinum-containing treatment is less than 6 months, excluding patients with primary platinum-refractory treatment (refers to relapse during the initial platinum-containing treatment or the end of first-line platinum-containing treatment Relapse within 28 days); 3. An Eastern Cooperative Oncology Group performance status of 0-1; 4. Expected survival >= 4 months; 5. According to the solid tumor efficacy evaluation standard (RECIST1.1), patients with at least one measurable lesion as a target lesion were confirmed by CT or MRI. If the target lesion is a lymph node, the short diameter is required to be greater than 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. Can swallow pills normally; 7. All acute toxic reactions resulting from prior anti-tumor therapy or surgery are alleviated to grade 0-1 (according to NCI CTCAE 4.03) or to the level specified in the inclusion/exclusion criteria.Hair loss and other toxins that researchers say do not pose a safety risk to patients are excluded. 8. There are sufficient organ and bone marrow functions, defined as follows: a) Absolute neutrophil count (ANC) >= 1,500/mm3 (1.5 x 10^9/L); b) Platelet count (PLT) >= 100,000/mm3 (100 x 10^9/L); c) Hemoglobin (Hb) > 9 g/dL (90 g/L); d) Serum creatinine (SCr) 2+), 24-hour urinary protein quantitative display must be (< 1 g); i) Thyrotropin (TSH) <= ULN; if abnormal ,FT3 (T3) and FT4 (T4) levels should be examined, FT3 (T3) and FT4 (T4) levels can be selected if normal. 9. Female subjects of childbearing age must have a serum pregnancy test within 3 days before starting the study medication and the result is negative, and they are willing to use a medically approved highly effective contraception during the study period and within 3 months after the last study medication administration ( (Eg: IUD, contraceptives or condoms); 10. Obtaining the patient's consent and having signed an informed consent form, willing and able to comply with planned visits, research treatments, laboratory tests and other testing procedures.
Exclusion criteria
Exclusion criteria: 1. Previous local radiotherapy for pelvis or lower abdomen; 2. Previously exposed to other anti-angiogenic small-molecule TKI drugs (permitted to bevacizumab treatment before, but not allowed such as pazopanib, sorafenib, regofenib, sildenib, etc.), PARP inhibition Drugs (such as olaparib, niraparib, etc.) or had used an anti-PD-1 antibody, an anti-CTLA-4 antibody, TCR-T, CAR-T and other immune therapy; 3. Patients with a clear history of allergies may be potentially allergic or intolerant to the biologics of apatinib, fluzoparil, and Camrelizumab; 4. 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 5. Other malignant tumors have occurred within 5 years (except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or controlled basal cell carcinoma of the skin); 6. Immunosuppressive drugs used within 14 days prior to the first use of Camrelizumab, 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). 7. 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). 8. 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). 9. Uncontrollable hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite with the optimal medical treatment. 10. 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) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy. 12. 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 h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease Control Rate;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactYuanguang Meng
The General Hospital of the People's Liberation Army (PLAGH)
Outcome results
None listed