Cervical cancer
Conditions
Interventions
Test Group:Trilaciclib combined with paclitaxel combined with carboplatin and radiotherapy
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance. 2. Age =18 years old, female; 3. Within 7 days before the administration of the first study intervention, the ECOG score was 0-1 points; 4. Expected survival period >=12 weeks; 5. Confirmed by pathology and histology as locally advanced cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma; 6. According to the RECIST 1.1 efficacy evaluation criteria for solid tumors, the patient has at least one measurable lesion. That is, in CT or MRI tests, the longest cross-sectional diameter of the lymph node lesion is =10mm or there is lymph node lesion. The minimum cross-sectional diameter is >=15mm. 7. Good functions of major organs, meeting the following criteria: 8. Blood routine test (under the condition of no blood transfusion and no use of hematopoietic stimulating factor drugs for correction within 14 days) : Hemoglobin (Hb) >=90g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelets (PLT) (PLT) >=80×10^9/L; 9. Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60mL/min; 10. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) =50%; 12. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 13. The doctor clinically determined that there was sufficient organ function. 14. Fertile subjects must use appropriate contraceptive methods during the study period and within 120 days after the study ends, have a negative serum pregnancy test within 7 days before enrollment in the study, and must be non-lactating subjects.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have occurred within 3 years prior to the start of treatment in this study or are currently present simultaneously. 2. Pathological indications include mucinous adenocarcinoma, clear cell adenocarcinoma, neuroendocrine tumors, and other special pathological types; 3. Unrelieved toxic reactions of grade =1 resulting from any previous treatment (according to the latest version of the General Terminology for Adverse Events [CTCAE] of the National Cancer Institute [NCI]), excluding alopecia and fatigue; Among them, neurotoxicity needs to be restored to <= grade 2 before enrollment. 4. Those who have received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before the start of the study treatment; Or there are long-term unhealed wounds or fractures; 5. Serious arterial or venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months prior to the start of the study treatment; 6. Those with a history of abuse of psychotropic drugs and unable to quit or with mental disorders; 7. Within 4 weeks prior to the start of the study, the applicant was currently participating in or had participated in other clinical researchers; 8. Those with a history of severe allergies; 9. Those who are known to be allergic to the active ingredients or excipients of the study drugs such as trilaciclib and carboplatin; 10. Subjects who, based on the researcher's judgment, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered to have other reasons that make them unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade =3 neutropenia during first-line chemotherapy treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhongjie Chen
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed