Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Ovarian Neoplasms

Neoplasms by Histologic Type

Sarcoma

Neoplasms, Connective and Soft Tissue

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

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Ovarian Cancer

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Doxorubicin

Liposomal doxorubicin

Niraparib

Topotecan

Dostarlimab

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Niraparib, 200 mg or 300 mg, daily dose

TSR042, intravenous infusion on Day 1 of every 21-day cycle at 500 mg for the 4 first cycles, followed by 1,000 mg on Day 1 of every 42-day cycle thereafter

Chemotherapies (Standard of care)

For Ovarian Cancer Patients Paclitaxel, 80 mg/m², Intravenous, Day 1, 8, 15 every 28 days Pegylated Liposomal Doxorubicin, 40 mg/m², Intravenous, every 28 days Topotecan, 4mg/m², Intravenous, Day 1, 8, 15 every 28 days

For Endometrial Cancer Patients Doxorubicin, 60 mg/m², Intravenous, every 21 days Paclitaxel, 80 mg/m², Intravenous, Day 1, 8, 15 every 28 days Gemcitabine, 800 mg/m², Intravenous, Day 1, 8 every 21 days

Combination of 2 drugs, a PARP Inhibitor and an Anti-PD-1

Niraparib + TSR-042 (Dostarlimab)

Chemotherapy Drugs

Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) \< 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is \<20%, progression-free survival (PFS) \<4 months, and OS \<1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.

Phase 2 :

Arm A - Niraparib

Arm B - Niraparib plus TSR-042

Arm C - Chemotherapy drugs

Peak the winner between the Arm A or the arm B

Phase 3:

Arm A: The best arm of the phase 2

Arm B: Chemotherapy drugs

Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

A Multicentric Randomized Phase II/III Evaluating TSR-042 (Anti-PD-1 mAb) in Combination With Niraparib (Parpi) Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy

RR is defined as the proportion of patients with a partial response or complete response 4 months after randomization

OS is the time from the date of the randomization until death due to any cause

PFS is the time from randomization to the date of event defined as the first documented progression (RECIST 1.1) or death due to any cause.

TTST is the time from the date of randomization to the earliest date of anti-cancer therapy start following study treatment discontinuation, or death by any cause in the absence of start of new anti-cancer therapy

PFS2 is the time from the date of randomization to the second objective disease progression, or death from any cause, whichever occurs first.

ORR is the proportion of patients with a best response of Complete Response or Partial Response.

Assessed with questionnaires to be completed by patient and collected frequently during the study

Tesaro, Inc.

ARCAGY/ GINECO GROUP

Neoplasms, Second Primary

Reproductive Control Agents

Central Nervous System Stimulants

Anti-Infective Agents

Megestrol

Megestrol Acetate

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Antineoplastic Agents, Hormonal

the patients were recepted chemotherapy alone

the patients were recepted chemotherapy combined with thalidomide and megestrol

the patients were recepted the best supportive without chemotherapy

the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy

Chemotherapy drugs

The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks

thalidomide and megestrol acetate

Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks

optimal support treatment

yangwei w yang, master

wenbin wb gao, doctor

To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors.

This study was to select 200 patients with advanced tumors with an estimated survival of ≥ 2 months. 50 patients were randomly assigned to each group. The patients were divided into chemotherapy group, chemotherapy combined with thalidomide and megestrol acetate group, The best supportive treatment group, the best supportive treatment combined with thalidomide and megestrol acetate group. The chemotherapy group and the best supportive treatment group were the control group. The combined group was administered continuously for 8 weeks according to thalidomide 100 mg qn po and megestrol acetate 0.16 qd po. Calculating the sum of the longest diameters of the target lesions from each patient before and 8 week after treatment. Patients in each group before treatment, 4th week, and 7th week were observed T cell subsets, B cell subsets, NK cell subsets and the expression of inflammatory cytokines. Through nutritional assessment Table (PG-SGA), Multidimensional Deficit Power Meter (MFSI-SF), Quality of Life Assessment Scale (EORTC QLQ-C30), Prognostic Assessment Form (GPS), Physical Status Assessment Form (ECOG) and lean body mass, upper arm muscle circumference and upper arm muscle area analysis of the effect of thalidomide combined with megestrol acetate on the nutritional status of patients with advanced cancer which reveal that thalidomide combined with megestrol acetate may improve the immune regulation and nutritional status of patients with advanced malignant tumors mechanism.

200 patients with advanced tumors with a predicted survival period of ≥2 months were selected, including 100 patients with chemotherapy indications (50 patients were divided into chemotherapy group and 50 patients were divided into chemotherapy combined with TH and MG group according to the random principle) and 100 patients without chemotherapy indications (50 patients were randomly divided into the best supportive treatment group and 50 patients were randomly divided into the best supportive treatment group with TH and MG according to the random principle). The chemotherapy alone group and the best supportive treatment group were the control group. The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks.

The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol

Prospective Clinical Study of the Effect of Thalidomide Combined With Megestrol Acetate on Lymphocyte, Inflammatory Factor Regulation and Nutritional Status in Patients With Advanced Malignant Tumors

Multidimensional deficient power assessment (MFSI-SF) was used in the present study. The MFSI-SF scale contains 30 subjects' subjective feelings，such as muscle soreness and memory loss. Subjects were scored according to the degree of each sensation (0-4). The MFSI-SF scale total score is the sum of each sensation score (0-120). The lower scores represent a better outcome and the higher scores represent a worse outcome.

Quality of Life Assessment Table (EORTC QLQ-C30) was used in the present study. The Quality of Life Assessment Table contains 28 subjects' subjective feelings and symptoms，such as tiredness and diarrhea within one week (A)，and two other indicators: health status，quality of life within one week (B). Subjects were scored according to the degree of each sensation (A 0-4) and (B 1-7). The Quality of Life Assessment Table is divided into two parts: the first part of the total score (0-112); the second part of the total scores (2-14). In the first part of the total scores: the lower scores represent a better outcome and the higher scores represent a worse outcome. In the second part of the total scores: the higher scores represent a better outcome and the lower scores represent a worse outcome.

The prognostic assessment by GPS scores which were calculated by detecting peripheral blood CRP and albumin from each tumor patients.

GPS scores：CRP \< 10 mg/l，albumin\> 35g/l，GPS 0；CRP \> 10 mg/l，albumin \> 35 g/l，GPS 1；CRP \> 10 mg/l，albumin \< 35 g/l，GPS 2. The lower scores represent a better outcome and the higher scores represent a worse outcome.

The performance status of patients with cancer is measured by the clinician through the ECOG score form (score:0-5)

Patient's waist circumference and weight were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate lean body mass by measurements of waist circumference and body weight

Patient's upper arm circumference and triceps skinfold thickness were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate Upper arm muscle circumference and upper arm muscle area by measurements of upper arm circumference and triceps skinfold thickness

Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.

Patients were detected Lymphocyte subgroups of 2 ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell subsets, NK cell subset, B cell subset(percentage)

2 ml of peripheral blood was taken from each patient. Flow cytometry was used to detect changes of inflammatory factor expression which include the IL-2, IL- 4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-17A, IL-17F, IL-21, IL-22, IFN-γ and TNF-α(ug/ml)

Scored Patient-Generated Subjiective Global Assessment（PG-SGA）form was used in the present study. The total score of PG-SGA is summed by the following four subscale scores（A+B+C+D）. The first measurement score（A）is self-assessed by the subject and consists of the following four parts: Weight Table（0-4），Eating Situation Table（0-6），Symptom Table （0-22），Activity and Body Function Table（0-3）. The remaining three measurements are completed by trained registered clinical physicians， dieticians，and nurses: Scale of relationship between disease and nutritional needs（B）（0-6），Metabolic demand scale（C）（0-9），Physical examination scale（D）（0-24）. The scoring was controlled by one researcher (H.R). The lower scores represent a better outcome and the higher scores represent a worse outcome.

Shenzhen Fifth People's Hospital

Analyzing biopsy samples that is preformed as part of the patient treatment.

Analyzing biopsy samples

tarek Saadi, Dr.

shlomit harpaz, Msc

Tarek Saadi, Dr.

Dror seliktar, Prof

Characterization of Cancer Tissue Using 3D Biosynthetic Materials. Using liver biopsy from stage 4 cancer patients, the investigators will evaluate and characterize the metastatic cells.

The investigators' biomaterial lab has developed an in vitro diagnostic system in which a cancer tumor is placed inside a 3D hydrogel. This material has similar properties to the human tissue and can visualize cell migration and proliferation. In this system, the investigators have already characterised human metastatic cells obtained from nude mice tumors. The diagnostic assay is able to evaluate the reduction in cell growth associated with anti-cancer drug therapy. The next step is to test the in vitro diagnostic system using human tissue samples from human patients, and to validate the system as a simple and effective a priori diagnostic tool for characterizing patient tumours.

Characterization of Cancer Tissue Using 3D Biosynthetic Material

biopsy will be placed inside 3D gel, and growth will be measured over 1 week time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib	NCT03651206	Ovarian Carcino... Endometrial Car...	Niraparib Niraparib + TSR... Chemotherapy Dr...	18 Years -	ARCAGY/ GINECO GROUP
The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol	NCT03777930	Cancer, Therapy...	Chemotherapy dr... thalidomide and... optimal support... thalidomide and...	18 Years -	Shenzhen Fifth People's Hospital
Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib	NCT03651206	Ovarian Carcino... Endometrial Car...	Niraparib Niraparib + TSR... Chemotherapy Dr...	18 Years -	ARCAGY/ GINECO GROUP
Characterization of Cancer Tissue Using 3D Biosynthetic Material	NCT02678078	Cancer	Analyzing biops...	18 Years -	Technion, Israel Institute of Technology

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