Recurrent Ovarian Carcinoma
Conditions
Brief summary
This is a prospective, single-arm, single-center registry study to investigate 6-month progression-free survival with Dalpiciclib, a CDK4/6 kinase inhibitor, plus letrozole in patients with unresectable refractory or resistant recurrent HR-positive, HER2-negative gynecologic solid tumors. Dalpiciclib is a CDK4/6 kinase inhibitor that selectively inhibits the activity of CDK4/6 kinase, so that the complex with Cyclin D cannot phosphorylate the downstream Rb protein and prevent cells from entering the S phase from G1 phase, thereby inhibiting cell proliferation and anti-tumor effects.
Interventions
Dalpiciclib 150mg qd, d1-21, repeated once every 4 weeks. Letrozole 2.5mg qd, repeated once every 4 weeks.
Sponsors
Fengzhi Feng
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients aged ≥18 years and ≤75 years; 2. Women with pathologically confirmed HR-positive, HER2-negative ovarian cancer or uterine tumors (including but not limited to high-grade serous ovarian cancer, low-grade serous ovarian cancer, ovarian endometrioid cancer, endometrioid cancer, low -grade endometrial stromal sarcoma, and uterine leiomyosarcoma) with evidence of focal recurrence or metastasis; Non-curative surgical resection or radiation therapy failing standard treatment, and no standard chemotherapy regimen. Er-positivity and/or PR-positive tumor cells were defined as 1% or more of all tumor cells that stained positively (as confirmed by the site investigator). Her2-negative was defined as 0/1+ on standard immunohistochemical (IHC) testing; An HER2/CEP17 ratio of less than 2.0 or a HER2 gene copy number of less than 4, as assessed by in situ hybridization (ISH), was confirmed by site investigator review. 3. Receipt of any previous systemic anticancer therapy for focal recurrent or metastatic disease. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Measurable lesions meeting RECIST 1.1 criteria or bone-only metastatic lesions (including osteolytic lesions or mixed osteolytic/osteogenic lesions). 6. Adequate organ and bone marrow function, defined as neutrophil count (ANC) ≥ 1500/mm3(1.5 × 109/L) (no growth factor administration within 14 days); Platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L) (no corrective therapy within 7 days); Hemoglobin (Hb) ≥ 9 g/dL (90 g/L) (no corrective therapy used within 7 days); Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min; Total bilirubin (BIL) ≤ 1.5 times upper limit of normal value (ULN); Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≤ 2.5 times The upper limit of normal (ULN), patients with liver metastases should be ≤ 5×ULN. 7. Use of a medically approved contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period for patients with potential childbearing potential; A negative serum HCG test must have been performed within 72 hours before study entry; And had to be non-lactating. 8. All acute toxic effects prior to antineoplastic therapy resolved to grade 0-1 (according to NCICTCAE version 5.0) or to the level specified in the inclusion/
Exclusion criteria
. Other toxicities, such as alopecia, that were deemed by the investigators not to pose a safety risk to patients were excluded. 9. There is no limit to the number of previous lines of endocrine therapy. 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month PFS rate | From the start of randomization to 6 months | according to RECIST1.1 criteria,the percent of participant whose PFS is more than 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) | From the start of randomization to a minimum of 1 year | Time from initiation of study protocol treatment to disease progression or death |
| Objective Response Rate（ORR） | From the start of randomization to a minimum of 1 year | Percentage of patients with CR/PR in the number of patients that whose tumour can be evaluated. |
| Disease Control Rate (DCR) | From the start of randomization to a minimum of 1 year | Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated. |
| Duration of response（DOR） | From the start of randomization to a minimum of 1 year | The time between the onset of efficacy and confirmation of tumor progression |
| Overall Survival(OS) | up to 2 years | The time from the start of treatment with this study protocol to the time of all-cause death of patients. |
Countries
China
Contacts
Primary ContactXiao Shang, PhD
Backup ContactZhi f Feng, PhD
Outcome results
None listed