Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Peritoneal Neoplasms

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Iniparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles

Body weight adjusted dose

1 hour intravenous infusion

Clinical Sciences & Operations

The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer.

Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.

Participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per RECIST criteria) and wished to remain on study.

Participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival.

Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 2, Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.

Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.

Clinical benefit rate was defined as the percentage of participants with complete response, partial response or stable disease according to RECIST criteria.

Progression-free survival was defined as the time interval from study entry until disease progression or death due to any cause, whichever came first.

In the absence disease progression or death, progression-free survival was censored at the last date the participant was known to be alive.

Overall Survival was defined as the time interval from study entry until death due to any cause.

In the absence of confirmation of death, progression-free survival was censored at the last date the participant was known to be alive.

Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels.

Sanofi

Symptoms and General Pathology

Postoperative Complications

Patients received lymphadenectomy during IDS

Patients did not receive lymphadenectomy during IDS

Systematic pelvic and para-aortic lymphadenectomy during IDS in lymphadenectomy group

lymphadenectomy

Qinglei Gao, MD, PhD

The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is:

Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy?

The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question.

The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The study included patients with histologically confirmed advanced epithelial ovarian cancer who received IDS at seven tertiary hospitals in China from 2006 to 2021. The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups. Propensity score matching (PSM) and overlapping weight (OW) analyses were performed to minimize selection bias.

Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer

Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer: a Multicenter Real-world Study

The progression-free survival (PFS) was defined as the duration from the initial diagnosis to the occurrence of recurrence, progression, death, or the latest follow-up, whichever came first.

Overall survival (OS) was described as the duration from the date of diagnosis to the date of death from any cause or the last follow-up date.

Tongji Hospital

Professor

Hypoglycemic Agents

Pharmaceutical Solutions

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Hematinics

Micronutrients

Insulin

Insulin, Globin Zinc

Chrysarobin

Liver Extracts

Vitamins

Trace Elements

Naso-jejunal tube was placed to the distal 15cm of Traitz ligament during the operation; short peptide enteral nutrient solution was heated by enteral nutrition pump and infused slowly and continuously 24 hours after the operation; during the period of infusion, the gastrointestinal tolerance of the patients was evaluated dynamically, and attention was paid to the absence of abdominal pain, diarrhea, constipation, vomiting, regurgitation, and misaspiration. According to the results of regular review of nutritional indicators, including hemoglobin, albumin, electrolytes, liver and kidney function, etc., increase the dosage of enteral nutrients in patients in appropriate amounts; patients with no abdominal distension after exhaustion and fluid intake, that is, the removal of nasojejunal tube, and replaced by oral intake of food.

Nutrient solution was evenly titrated starting 24 hours after surgery. Configuration of nutritional solution: glucose and medium/long-chain fat emulsion as the main energy substances to provide calories, diabetic patients depending on the blood glucose level to adjust the pancreatic glucose ratio, and then assisted by subcutaneous injection of insulin to control blood glucose, if necessary, pay attention to the total amount of rehydration fluids, electrolytes, vitamins and micronutrient supplementation. Nutritional solution was evenly mixed in the laminar flow clean table and infused through the intravenous route, and oral feeding was started after exhaustion.

A naso-jejunal tube was placed in the operation, which is placed 15 cm below Traitz's ligament. A short-peptide enteral nutrient solution was heated by an enteral nutrient pump and infused into the patients within 24 hours after the operation. Before and at the end of the infusion, physiological saline was given to flush the tube, and at the end of the infusion, the catheter was closed to prevent liquid reflux and blockage of the tube. The catheter should be clamped shut at the end of the infusion. During the infusion period, the patient's gastrointestinal tolerance was dynamically evaluated. According to the results of a regular review of nutritional indicators, including hemoglobin, albumin, electrolytes, liver and kidney function, etc., increase the amount of enteral nutrients; remove the nasojejunal tube when the patient has no abdominal distension after exhaustion and feeding; and change to feeding through the mouth.

Transnasal jejunal tube

A uniform drip of nutritional solution was started 24 hours postoperatively. Configuration of nutritional solution: glucose and medium/long-chain fat emulsion as the main energy substances to provide calories, calculated at 30 \~ 35 kcal/(kg-d), glucose-fat ratio is 6:4, pancreatic glucose ratio for those without a history of diabetes mellitus is 1:6 \~ 8, and for diabetic patients depending on the level of glucose, pancreatic glucose ratio is 1:3 \~ 4, and then assisted with subcutaneous injections of insulin to control glucose, if necessary. Pay attention to the total amount of rehydration fluid, electrolytes, vitamins, and trace elements supplemented. Mix the nutrient solution evenly in the laminar flow clean table and infuse it through the route at 2500\~3000 ml/d; the infusion time is 8\~12 h/d. After exhaustion, start to eat through the mouth.

Transvenous access

Luo Chengyan, Doctor

This is a single-center, unblinded, prospective observational study, and the objective is to compare the effects of enteral nutrition via nasojejunal tube and parenteral nutrition via vein on patients' early recovery and prognosis who undergo tumor cytoreduction for ovarian cancer.

Ovarian cancer is the most lethal disease among gynecological malignancies, and its treatment is a comprehensive one mainly based on surgery. The perioperative nutritional status of patients affects their postoperative recovery, subsequent adjuvant therapy, and their prognosis. Hence, nutritional support therapy should be initiated for such patients in the early postoperative period to prevent further malnutrition. Conventional postoperative nutritional support therapy is performed through parenteral nutrition via vein, while the application of enteral nutrition via the nasojejunal tube in the postoperative period of ovarian cancer has not been reported in the literature. Therefore, in this study, the investigators took advantage of the characteristics of long surgical incisions and the wide surgical scope of ovarian cancer to investigate the effects of placing a nasojejunal tube during the operation and early enteral nutrition on postoperative recovery and prognosis in patients with advanced ovarian cancer, with the aim of accelerating the postoperative recovery of the patients, decreasing the incidence of postoperative complications, supplementing adjuvant chemotherapy in time, improving the survival outcome of the patients with advanced ovarian cancer, and providing gynecologists with a basis for enteral nutritional support therapy via nasojejunal tube after ovarian cancer surgery. In this study, the patients placed with a nasojejunal tube during the operation and enteral nutrition after the operation were included in the observation group, and the patients without a nasojejunal tube and parenteral nutrition after the operation were included in the control group. And the two groups were compared in terms of the indicators of postoperative recovery, the incidence of complications within the 30 days after operation, the cost of hospitalization, hospital stay, the interval between the operation and the first chemotherapy, the survival outcome, etc. The data involved in the study came from patient files, hospital databases, and long-term follow-up results.

Effect of Early Enteral Nutrition on Postoperative Recovery of Ovarian Cancer Patients

Clinical Study on the Effect of Early Enteral Nutrition Implemented by Placing Nasojejunal Tube During Ovarian Cancer Surgery on Patients' Postoperative Recovery and Prognosis

To record the patient's hemoglobin on postoperative days 7 and 14 according to routine blood results

To record intervals from surgery to the initiation of postoperative exhaustion and defecation according to the medical record

To record the hospital stay after surgery and intervals from surgery to initiation of postoperative chemotherapy according to the medical record

To record the cost of a patient's hospitalization of peri operation according to the medical record

To record the incidence of complications patient's postoperative complications for 30 days according to medical records, including: fever, intestinal obstruction, intestinal fistula, thrombosis, pulmonary embolism, poor incision healing, etc.

To assess patients' quality of life scores on postoperative day 3 according to functional assessment of cancer therapy-ovary cancer (FACT-O) vision 4.0, with a minimum value of 0 and a maximum value of 156. The higher scores are, the better quality of postoperative survival is.

To record the patient's serum sodium and potassium on postoperative days 7 and 14 according to biochemical results.

To record the number of patients with abnormal liver function within 30 days postoperatively according to biochemical results. Abnormal liver function was defined as serum alanine aminotransferase and/or aspartate aminotransferase higher than 2.5 times the upper limit of normal values.

To record the number of patients with abnormal renal function within 30 days postoperatively according to biochemical results. Abnormal renal function was defined as serum creatinine and/or urea higher than 2.5 times the upper limit of normal values.

To record the patient's serum albumin on postoperative days 7 and 14 according to biochemical results.

Survival outcomes at 3 years postoperatively, including progression, recurrence, death, and survival

To record the incidence of complications related to tube placement in patients in the nasojejunal group according to medical records

Luo Chengyan

chief physician

Fallopian Tube Cancer

Gastrointestinal Agents

Muromonab-CD3

Catumaxomab

Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).

catumaxomab

Michael V Seiden, MD, Ph.D

The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.

A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter or port. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 4 months (includes the baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months follow-up), with post-study follow-up every 3 months for 2 years.

Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule (EpCAM) on tumor cells and CD3 (cluster of differentiation 3) on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells \[DCs\] and natural killer \[NK\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy

An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x Anti-CD3) in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy

Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.

Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die

Fresenius Biotech North America

Neovii Biotech

4 dose series (10-20-50-150 micrograms) within 21 days

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Anne Kuan

Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days

Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy

Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)

Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)

Number of Participants Who Survived (Post-study at 24 Month Visit)

Only 1 patient received 3rd-look laparoscopy/laparotomy as determined by the investigator and no residual disease was found.

Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT00677079	Primary Periton... Advanced Epithe...	Iniparib	18 Years -	Sanofi
Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer	NCT06385912	Ovarian Cancer Postoperative C... Neoadjuvant The... Lymph Node Exci...	lymphadenectomy	-	Tongji Hospital
Effect of Early Enteral Nutrition on Postoperative Recovery of Ovarian Cancer Patients	NCT06236958	Advanced Epithe...	Transnasal jeju... Transvenous acc...	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy	NCT00377429	Ovarian Cancer	catumaxomab	18 Years -	Neovii Biotech
Effect of Early Enteral Nutrition on Postoperative Recovery of Ovarian Cancer Patients	NCT06236958	Advanced Epithe...	Transnasal jeju... Transvenous acc...	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT00677079	Primary Periton... Advanced Epithe...	Iniparib	18 Years -	Sanofi
Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy	NCT00377429	Ovarian Cancer	catumaxomab	18 Years -	Neovii Biotech

Spots Global Cancer Trial Database for advanced epithelial ovarian cancer