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Evaluation Compared with traditional NACT, whether PIPAC can increase the incidence of CRS3 determines the rationality of choosing PIPAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | The treatment group received PIPAC plus intravenous NACT (paclitaxel or docetaxel plus two cycles of carboplatin) |
|
| control group | No Intervention | The control group received intravenous NACT (paclitaxel or docetaxel plus carboplatin for three cycles) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPAC | Procedure | This is a randomized, controlled, open, and parallel design clinical study aimed at evaluating the efficacy and safety of PIPAC. Sixty patients with stage IIIC-IVA high-grade serous ovarian cancer (HGSOC) were randomly assigned to either the traditional NACT or PIPAC group for treatment, and the incidence of CRS3 was then assessed. This study is exploratory, and statistical analysis will be conducted after all cases have been treated and followed up, providing a basis for future clinical studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Can PIPAC increase the incidence of CRS3 | The primary objective of this study is to evaluate whether PIPAC can increase the incidence of CRS3 compared to traditional NACT, thereby determining the rationale for choosing PIPAC. The main evaluation metric is derived from the CRS scoring system. According to the ICCR guidelines, the CRS score is obtained through pathological analysis of the peritoneal tissue collected during IDS. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
1) Patients with other malignancies or have received any form of chemotherapy, radiotherapy and targeted therapy for this disease in other hospitals.
2) Diagnose complete intestinal obstruction. 3) Subjects who rely entirely on parenteral nutrition. 4) Subjects with decompensated ascites; 5) Subjects with severe abdominal infection (peritonitis); 6) Subjects with extensive adhesions in the abdominal cavity; 7) Subjects who underwent tumor debulking surgery and gastrointestinal resection reconstruction simultaneously; 8) Subjects with portal vein thrombosis; 9) Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart Functional insufficiency, ejection fraction less than 50%, difficult to control hypertension, etc.); 10) Allergy to chemotherapy drugs in the past; 11) Patients with serious cardiopulmonary, liver and kidney, blood system or mental illness and drug abuse; 12) Expected life is less than 12 weeks. 13) Patients who have participated or are currently participating in other clinical trials within 3 months; 14)Other conditions that the researchers judged the patient to be unsuitable for inclusion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaosen Li Li | Contact | 18343116682 | xiaosensen@jlu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | 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 |
| 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 |
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