solid cancer
Conditions
Interventions
Case series:cisplatin, niraparib, sintilimab
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent; 2. Aged 18-75 years old; 3. Histological or cytologically confirmed lung squamous cell carcinoma, esophageal squamous cell carcinoma, cervical squamous cell carcinoma, small cell lung cancer, ovarian cancer, which meets any of the following conditions: (1) Treatment of lung squamous cell carcinoma first line and above failed; (2) Treatment of cervical squamous cell carcinoma and above fails; (3) First-line treatment failure of small cell lung cancer (recurrence =3 months; (9) There are sufficient organ and bone marrow functions during the screening period, as defined below: (10) Neutrophil count (ANC) >=1500/mm3 (1.5x10^9/L); (11) Platelet count (PLT) >=100,000/mm3 (100x10^9/L); (12) Hemoglobin (Hb) >=9 g/dL (90 g/L); (13) serum creatinine =2+, 24-hour urine protein quantitation shows that the protein must be <= 1g; (18) Thyroid stimulating hormone (TSH) <=upper normal limit (ULN); if abnormalities should be examined for FT3 and FT4 levels, FT3 and FT4 levels may be normal. (19) Women of childbearing age must have a negative pregnancy test (serum or urine) within 3 days prior to the first study drug administration, and voluntarily use the appropriate method for contraception during the observation period and within 8 weeks after the last administration; for men, For surgical sterilization or consent to use appropriate methods of contraception during observation and within 8 weeks after the last dose; (20) all adverse events return to <=1 or clinically stable; (21) Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the program requirements.
Exclusion criteria
Exclusion criteria: 1. previous application of PARP inhibitors (Olapali, Rucaparib and Niraparib, etc.); 2. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >=200 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV- RNA is higher than the lower limit of detection of the analytical method) or combined with hepatitis B and hepatitis C; Note: The HBV viral load must be =2 grade, arrhythmia (including >450 ms for men with QTc interval, >470 ms for women) and grade >=Grade II congestive heart failure (New York Heart Association classification); 8. has a variety of factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 9. a severe infection within 4 weeks prior to the first dose (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5 °C during screening/first administration; 10. merge any active autoimmune disease or have a history of autoimmune disease (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 in childhood asthma, can be included without adult intervention after adult; asthma requiring medical intervention for bronchodilators cannot be included); 11. Patients who require long-term systemic use of corticosteroids. Patients with intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroids due to COPD, asthma may be enrolled; 12. major surgery, open biopsy or significant trauma within 28 days prior to enrollment; m) a history of allogeneic organ transplantation or a history of allogeneic hematopoietic stem cell transplantation; n) Other circumstances that the investigator believes are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Maximum tolerable dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;objective response rate; | — |
Countries
China
Contacts
Public ContactYi Hu
China PLA general hospital
Outcome results
None listed