advanced solid cancer
Conditions
Interventions
Case series:fuzuoparib (PARP inhibitor) in combination with Albumin Palitaxel and Camrelizumab (PD-1 inhibitor)
Sponsors
The General Hospital of the People's Liberation Army (PLAGH)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Histological or cytologically confirmed patients with advanced lung cancer, cholangiocarcinoma, and urothelial carcinoma, including one of the following: 1) patients with cholangiocarcinoma who have not been treated; 2) After failure of first-line treatment of EGFR wild NSCLC patients; 3) After failure of first-line treatment in patients with SCLC; 4) patients with urothelial carcinoma progress or relapse after receiving a first-line platinum-containing regimen; 3. ECOG score 0-1; 4. At least one measurable lesion (according to RECIST 1.1 standard, the length of CT scan of tumour lesion is more than 10 mm, and the short diameter of CT scan of lymph node lesion is more than 15 mm); 5. The life expectancy is more than 3 months; 6. The main organs have normal functions, and there are no serious abnormal functions of blood, heart, lung, liver, kidney, bone marrow and immunodeficiency diseases. Laboratory tests meet the following requirements: Routine blood test: (1) Hemoglobin (Hb) > 90g/L; (2) Leukocyte count (WBC) > 4.0 *10^9/L, neutrophil count (NEUT) > 2.0 *10^9/L; (3) Platelet count (PLT) > 100 *10^9/L; Blood biochemistry: (4) Serum creatinine (SCr) 60 ml/min) (Cockcroft-Gault formula); (5) Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); (6) The level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is less than 2.5 times the upper limit of normal value (ULN). Urine routine: (7) Urinary protein 2+), 24-hour urinary protein quantitative display must be (< 1 g); Thyroid function: (8) 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. Coagulation function: (9) The international standardization ratio INR is less than 1.5 ULN; (10) Partial thromboplastin time APTT < 1.5 ULN; (11) Prothrombin time PT < 1.5 ULN; 7. The results of blood pregnancy test for women of childbearing age were negative, and appropriate contraceptive methods should be used voluntarily during the observation period and within 8 weeks after the last study drug was given. For men, appropriate contraceptive methods should be used for surgical sterilization or consent during the observation period and within 8 weeks after the last study drug was given; 8. Subjects volunteered to participate in the study and signed an informed consent (ICF); 9. It is expected that those with good compliance will be able to follow up the curative effect and adverse events as required by the scheme.
Exclusion criteria
Exclusion criteria: 1. Received radiotherapy, surgery, chemotherapy, immunotherapy within 28 days prior to the first administration; 2. Patients with active brain metastases who have clinical symptoms and need treatment; 3. Patients who prior to PD-1/PD-L1/CTLA-4 antibody, taxane and PARP inhibitors; 4. Use immunosuppressive drugs within 14 days prior to the first adminatration; 5. Active autoimmune disease or autoimmune disease disease; 6. There is an active infection within 14 days before the first adminatration; 7. Severe traumatic injury, fracture within 4 weeks; 8. There are active heart disease in the 6 months before the first adminatration, including myocardial infarction, severe/unstable angina. Left ventricular ejection fraction(LVEF) <50%, poorly controlled arrhythmia; 9. Any other malignant tumor was diagnosed within 3 years, with the exception of well-treated basal cells or squamous cell skin cancer or cervical carcinoma in situ; 10. Known to be allergic to the study drug or any of its excipients; or to have a severe allergic reaction to other monoclonal antibodies; 11. Screening period for human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C; 12. Nausea, vomiting, diarrhea that cannot be swallowed or uncontrollable; 13. According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject, or affect the subject's completion of the study (eg, poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other situation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Tolerable Dose; | — |
Countries
China
Contacts
Public ContactYi Hu
The PLA General Hospital
Outcome results
None listed