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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. The majority of ovarian cancer patients with standardized treatment, including tumor cell reduction and postoperatively platinum-based combination chemotherapy, will still experience tumor recurrence and multiple recurrences within 6-18 months.With the increase in the number of recurrences, the intertherapeutic period will shorten and eventually drug resistance will emerge.The purpose of treatment for recurrent ovarian cancer is mainly to improve the quality of life of patients and prolong survival. CSPC OUYI PHARMACEUTICAL CO., LTD has successfully developed Paclitaxel (Albumin-Bound) and the bioequivalence test results show good consistency with Abraxane.To evaluate the efficacy and safety of Paclitaxel (Albumin-Bound) combination with carboplatin in Chinese patients with platinum-sensitive recurrent ovarian cancer, this clinical study is planned.
This study is a multicenter, open, single arm, phase 2 clinical study in patients with platinum-sensitive recurrent ovarian cancer.75 patients were planned to be enrolled, and the eligible patients were given the following regimen: Paclitaxel (Albumin-Bound) 130 mg/m^2, i.v., d1, d8;Carboplatin AUC 5, i.v.,d1;Every 21 days is a cycle, a total of 6 cycles.This study will be divided into three stages.The baseline period:Patients will complete screening tests at baseline to assess eligibility for inclusion criteria.Treatment period:(from the first dose to the last treatment cycle).Imaging tumor assessment was performed every 2 cycles (i.e. 6 weeks).Follow-up period:At the end of the study, patients were followed up by telephone or at the study center every 3 months to collect survival status and subsequent antitumor treatment until death or loss of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm | Experimental | Paclitaxel (albumin-bound) 130 mg/m2, i.v., d1, 8; Carboplatin AUC 5, i.v. d1; repeat every 21days, 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel (albumin-bound) | Drug | The dose of intravenous chemotherapy drug is calculated according to the body surface area.When patients have serious adverse events, dose suspension and dose reduction are allowed. Paclitaxel (albumin-bound) was allowed to be reduced only twice (20% standard dose reduction in the first dose and 20% lower in the second dose).Once the dose is reduced, all subsequent doses should be maintained at reduced dosage. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | From date of randomization until the date of first documented progression or died | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | The proportion of patients with tumor shrinkage reaching a certain amount and for a certain period of time, including cases of CR PR. | up to 36 months |
| Overall survival(OS) |
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Inclusion Criteria:
Age :18-75years old;
Histopathological confirmed epithelial ovarian cancer/fallopian tube/peritoneal cancer; Mucinous adenocarcinoma and low-grade serous carcinoma are excluded;
Recurrence more than 6 months after the last treatment with taxanes and platinum; Relapse ≤ 3 times; Recovered from the toxicity of the previous chemotherapy to ≤ 1 (hair loss ≤ 2);
Relapse confirmed by imaging and CA125:
i. Adenocarcinoma cells are confirmed by cytology in the pleural and ascites; ii. Imaging considers that there is tumor recurrence, but the lesions do not meet the measurable standard. They are all small lesions (longest diameter <10 mm or pathological lymph node short diameter ≥10 mm to <15 mm). CA125 ≥ normal upper limit (ULN) 2 times, and CA125 is still showing an upward trend after rechecking after 1 week; c) Patients with recurrence can receive a second cytoreductive surgery. Postoperative R0 resection or residual tumor can be included in the group.
ECOG score 0-1;
Expected survival time ≥ 3 months;
Laboratory tests: absolute neutrophil count (ANC): ≥1.5×10^9/L; platelets (PLT):≥100×10^9/L;hemoglobin (Hb): ≥90g/L (blood transfusions are allowed to meet or maintain the targets);
Liver and renal function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or \
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yangchun Sun | Contact | 13661355755 | yfc1303700@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lingying Wu | Chinese Academy of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D013660 | Taxes |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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|
|
From date of randomization until the date of death from any cause
| up to 36 months |
| disease control rate(DCR) | including CR, PR, SD | up to 36 months |
| hematological toxicity and non-hematological toxicity | including hematological toxicity and non-hematological toxicity | up to 36 months |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |