Symptoms and General Pathology

All Conditions

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Wounds and Injuries

Behaviors and Mental Disorders

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Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hyperthermia

Fever

Carcinoma

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Ovarian Diseases

Adnexal Diseases

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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients will undergo only CRS, HIPEC and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.

A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.

CRS+HIPEC

Patients will undergo only CRS and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.

CRS alone

Hongbing Cai, Doctor

Zhen Li, Doctor

Yuanzhen Zhang, Doctor

A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.

A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation

A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes

The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.

The overall survival interval was the time between diagnosis and death or last follow-up.

The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 9 months since histological diagnosis.

The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 12 months since histological diagnosis.

Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0

CAI Hongbing

Dr. Prof.

Disease Progression

Antineoplastic Agents

All Drugs and Chemicals

Poly(ADP-ribose) Polymerase Inhibitors

A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Testing of homologous recombination deficiency

Lei Li, M.D.

The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

HRD and Resistance to PAPPi in EOC Patients

Correlation Between Homologous Recombination Deficiency Status and Resistance to PARP Inhibitors in Chinese Epithelial Ovarian Cancer Patients

Progression-free survival after the start of PARPi

Overall survival after the start of PARPi

Severe adverse events after the start of PARPi

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital
HRD and Resistance to PAPPi in EOC Patients	NCT05310370	Epithelial Ovar... Homologous Reco... Homologous Reco... Poly(ADP-ribose... Drug Resistance Progression-fre... Overall Surviva...	Testing of homo...	18 Years -	Peking Union Medical College Hospital
HRD and Resistance to PAPPi in EOC Patients	NCT05310370	Epithelial Ovar... Homologous Reco... Homologous Reco... Poly(ADP-ribose... Drug Resistance Progression-fre... Overall Surviva...	Testing of homo...	18 Years -	Peking Union Medical College Hospital
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital

Spots Global Cancer Trial Database for homologous recombination repair gene mutation