NCT05792254

Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer

Efficacy and Safety of Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer: a Single-center Prospective Single-arm Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Twenty-five patients with FIGOⅡ-Ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with Huaier granules. During the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity. This is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Twenty-five patients with FIGOⅡ-Ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with Huaier granules. During the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity.

Detailed description

Primary Objective: To evaluate the efficacy of Huai er granule in the treatment of stage I primary ovarian cancer, fallopian tube cancer and peritoneal cancer Secondary objectives: 1. To analyze the safety of Huaier granule in the treatment of ovarian fallopian tube cancer and peritoneal cancer after operation; 2. To analyze the influence of Huaier granule on the quality of life of postoperative patients with ovarian fallopian tube cancer and peritoneal cancer Exploratory objective: To evaluate the efficacy of Huaier granule in patients with BRCA mutation and BRCA wild-type ovarian cancer

Conditions

• Primary Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Huaier granule	Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-12-01
• Completion: 2025-05-01
• First posted: 2023-03-31
• Last updated: 2023-03-31