cervical cancer
Conditions
Interventions
Case series:sintilimab combined with Pemetrexed
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent provided; 2. female,18-75 years of ages; 3. Recurrent or metastatic cervical cancer patients confirmed by pathology and imaging,Recurrent or metastatic cervical cancer patients who previous first-line chemotherapy with platinum regimen failed or relapsed; 4. Participants must have a measurable disease (RECIST v1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; predicted survival period (> 3 months); 6. Organ and hematopoietic function as defined below:Absolute neutrophil (ANC)>= 1.5 x 10^9/L, platelets (PLT)>= 80 x 10^9/L, Hemoglobin (HGB)>= 80g/L,total bilirubin (< 1.5 * ULN) (upper limit of normal value),ALT or AST (< 2.5 * ULN); if there is any. For liver metastasis, ALT or AST were less than 5 * ULN; 7. For women of child-bearing age, a negative urine or serum pregnancy test should be conducted 7 days prior to the first study drug administration;All subjects of childbearing potential must agree to use efficient contraceptive methods that result in a failure rate of < 1% per year during the study treatment period and for at least 3 months after discontinuation from study treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with any autoimmune disease [i.e.,but not limited to, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism ];patients with vitiligo ;Asthma that requires intermittent use of bronchodilators or other medical intervention should be excluded. 2. Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry. 3. Having undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 4. A past history of allergic reactions attributed to any macromolecular protein preparation/monoclonal antibody, or any other composition of the investigational product; 5. Subjects having clinical symptoms of metastases to central nervous system (such as cerebral edema requiring steroids intervention, or brain metastasis progression); Previous treatment of brain or meningeal metastasis Clinical stability less than 2 months Subjects that requires systemic corticosteroids (dose equivalent to or above 10 mg prednisone daily) 6. Uncontrolled cardiac symptoms and diseases, such as (1) heart failure greater than NYHA II;(2)unstable pectoris; (3) myocardial infraction in a year; (4) supraventricular or ventricular arrhythmia in need of treatment or intervention(5)The LVEF at rest was less than 50% on echocardiography. 7. Patient should be after the last dose of chemotherapy, radiotherapy and surgery, less than 5 drug half-lives or less than 4 weeks (Take longer )before experimental treatment. If previously received nitrosourea or mitomycin chemotherapy, the time interval between the end of chemotherapy and the study group was less than 6 weeks. Adversed effect (except hair loss) caused by previous treatment shout recover to 38.5 °C during the screening period and prior to the first dose (upon the judgment by the investigator, patients with fever caused by tumor can be enrolled); 9. HIV positive tests or positive syphilis or active hepatitis; 10. Subjects who have participated in other clinical trials, or have completed other clinical trials within 1 month 11. Patient may receive other systematic anti-timor therapy in research period. 12. Prior therapy with an anti-PD1, anti-PDL1, anti-CTLA-4 agent or any other drug specifically targeting checkpoint pathways); 13. Subjects had previously received pemetrexed treatment. 14. Having received a live vaccine within 4 weeks prior to the first dose of investigational drug; 15. A history of alcoholism or drug abuse. 16. Pregnant or lactating women. 17. Any mental condition that hinders the understanding or provision of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactGuiling Li
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed