Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Capecitabine

Oxaliplatin

Endothelial Growth Factors

Mitogens

Thalidomide

Endostar protein

Endostatins

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Two Anti-angiogenesis Drugs（Endostar and Thalidomide） Combined With Chemotherapy for the patients of Advanced Colorectal Cancer

chemotherapy alone for the patients of Advanced Colorectal Cancer

Endostar:30 mg/d, CIV (continous intravenous pumping) on day 7 of each 21 day cycle，5 days before the chemotherapy is the first day; Thalidomide:100-200mg/d,PO (peros) on day 14 of each 21 day cycle Number of Cycles: 6 cycle or progression or unacceptable toxicity develops.

Two Anti-angiogenesis Drugs（Endostar and Thalidomide）

CapeOX (also called XELOX) is a chemotherapy regimen consisting of capecitabine (trade name Xeloda) combined with oxaliplatin.

Oxaliplatin 130mg/m2 IV over 2 hours,day1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks Number of Cycles: 6 cycle or progression or unacceptable toxicity develops.

Pure chemotherapy（Xelox）

FU DAI, Master

YANGYI BAO, Bachelor

CHANGLU HU, Bachelor

AIGUO LIU, Doctor

The purpose of this study is to determine whether Endostar pumping into vein with Thalidomide are more effective in the treatment of Advanced Colorectal Cancer (ACRC).

Endostar have anti-tumor activity by against vascular endothelial growth factor.

Thalidomide is a therapeutic for insomnia and vomiting. It is also used for tumor treatment as an Anti-angiogenesis drug and immune regulator in recently years.

1. Evaluated the therapeutic effects and survival benefits of ACRC treatment by using the Endostar and Thalidomide combined with XELOX regimens. (including the RR, DCR, PFS, and QOL);
2. Evaluated the security and tolerance by treating with Endostar and Thalidomide (the occurrence of adverse reaction, the degree, the regularity and control measures, etc.);
3. Detected the histological markers (VEGF/VEGFR, PDGF/PDGFR, BFGF/FGFR, cox-2, Her-2, K-Ras and p53) before the patients into the group. Make a retrospective analysis of individual molecules indicators to guide significant therapy of ACRC.

Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical

Adoption of internationally accepted evaluation oncology research progression-free survival (PFS) as a main observation indexes.

Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment. divided into complete remission (CR), partial response (PR), stable (SD) and development (PD). The total effective rate (RR) refers to the percentage of CR + PR.

Anhui Provincial Cancer Hospital

Anhui Jimin Cancer Hospital

Simcere Pharmaceutical Co., Ltd

The First People's Hospital of Hefei

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ascites

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

Ovarian Cancer

Ovarian Epithelial Cancer

Aflibercept

Participants with advanced ovarian cancer administered placebo in the double-blind (DB) period.

In the open-label (OL) period, participants had the option to receive aflibercept or be withdrawn from the study.

Participants with advanced ovarian cancer administered aflibercept in the double-blind (DB) period.

In the open-label (OL) period, participants had the option to continue to receive aflibercept or be withdrawn from the study.

4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.

aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

Placebo was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.

Placebo

4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the OL period.

Walter GOTLIEB

This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer.

Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer

Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.

The study included:

* A Thirty (30)-day screening phase
* The double blind treatment period for a minimum of 60 days. Day 1 of the double-blind treatment period was defined as the date of the qualifying paracentesis (ie, withdrawal of \>= 1 Liter of ascitic fluid). Participants were randomized after adequate recovery from the qualifying paracentesis (The first dose was administered on Day 1 or Day 2).
* The optional open-label extension (until treatment discontinuation criteria were met)
* A posttreatment follow-up phase lasting 60 days.

Criteria for discontinuation included:

1. Participant or his legally authorized representative request discontinuation
2. In the Investigator's opinion, continuation of treatment would be detrimental to the participant's well being, such as disease progression, unacceptable toxicity, noncompliance, or logistical considerations
3. Sponsor request
4. Intercurrent illness that prevented further administration of investigational product(IP)
5. More than 2 IP dose reductions
6. Unacceptable adverse events (AE) not manageable by symptomatic therapy, dose delay, or dose modification
7. Arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset or worsening of preexisting angina
8. Radiographic evidence of intestinal obstruction (for example, dilated loops of bowel accompanied by air-fluid levels) or gastrointestinal perforation (for example, presence of extraluminal gas) requiring surgical intervention

Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Effect of Intravenous Aflibercept Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

TRP was defined as the number of days between the date of randomization and the date of the first post-randomization paracentesis.

For participants who did not undergo a postrandomization paracentesis on study, TRP was calculated from randomization to the end of the double-blind treatment period.

AIM 4 symptoms (abdominal discomfort, abdominal bloating, abdominal pain, and ability to move normally) are scored from 0 to 5, where higher scores represent worst outcomes. An AIM total score ranges from 0-20.

A plot for (The AIM questionnaire total score - Baseline score) versus time were generated. AIM AUC represents the overall improvement (scored positive) if the area is below the baseline value or worsening (scored negative) if the area is above the baseline. AIM AUC for a participant is the sum of individual areas representing improvement (+) or worsening (-).

60-Day FOP was defined as the total number of paracenteses performed within the first 60 days after randomization during the double blind treatment period.

Free aflibercept and VEGF-bound aflibercept plasma concentrations were measured by separate enzyme-linked immunosorbent assay (ELISA). The limit of quantitation of free aflibercept was 15.6 ng/mL, and of VEGF-bound aflibercept was 43.9 ng/mL.

Peak free aflibercept was estimated at the end of Cycle 1 (C1) administration. The median free and VEGF-bound trough concentrations were determined for each participant beyond Cycle 3 (C3), then mean values were estimated from these median values.

Regeneron Pharmaceuticals

Sanofi

Adverse events were collected and reported per arm only as there was no washout period between the double-blind and open label treatment periods.

Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.

Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.

Total

< 35 years

>=35 to <45 years

>=45 to <55 years

>=55 to <65 years

>=65 to <75 years

>=75 years

Baseline characteristics are reported for the randomized population

Age, Customized

Sex: Female, Male

Caucasian

Black

Asian, Oriental

Race/Ethnicity, Customized

Trial Transparency Team

The intent-to-treat (ITT) population - all participants who were randomized in the study.

Time to Repeat Paracentesis (TRP)

The intent-to-treat (ITT) population - all participants who were randomized in the study, and had evaluable AIM scores.

Area Under the Curve (AUC) for Participant Assessed Ascites Impact Measure (AIM)

60-Day Frequency of Paracentesis (FOP)

Peak Free Aflibercept (C1) (N=20, N=15)

Trough Free Aflibercept (Beyond C3) (N=15, N=19)

Trough Bound Aflibercept (Beyond C3) (N=16, N=17)

Participants with advanced ovarian cancer administered placebo or 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period.

Double Blind (DB) Period

Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.

Open-Label (OL) Period

The analysis was performed using the safety population with evaluable blood samples. 42 participants were evaluated.

Plasma Levels of Free and VEGF-bound Aflibercept

Double Blind Treatment (DB) Period

Open Label Treatment (OL) Period

Diseases and Abnormalities at or Before Birth

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Adenomatous Polyposis Coli

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Bevacizumab

Antineoplastic Agents, Immunological

Patients receive three days before the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform) 4.5 mg of the fluorescent tracer bevacizumab-IRDye800CW.

Patients receive three days before the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform) 10 mg of the fluorescent tracer bevacizumab-IRDye800CW.

Patients receive three days before the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform) 25 mg of the fluorescent tracer bevacizumab-IRDye800CW.

Intravenous administration of a 4.5 mg, 10 mg or 25 mg of Bevacizumab-IRDye800CW 3 days prior to the fluorescence endoscopy procedure.

Bevacizumab-IRDye800CW

A flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope, which is used for the surveillance endoscopy procedure.

Near infrared fluorescence endoscopy platform

Wouter B Nagengast, PharmD MD PhD

Jan Jakob Koornstra, MD PhD

Jan H Kleibeuker, MD, senior full professor

There is a need for better visualization of polyps during surveillance endoscopy in patients with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the determination of the optimal tracer dose.

Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW

Visualization of a VEGF-targeted Near-Infrared Fluorescent Tracer in Patients With Familial Adenomatous Polyposis During Fluorescence Endoscopy A Single Center Pilot Intervention Study

The main objective of this study is to determine the sensitivity of the fluorescent tracer bevacizumab-IRDye800CW and the near-infrared fluorescence endoscopy platform in identifying adenomatous polyps during surveillance endoscopy in patients with Familial Adenomatous Polyposis (FAP).

In this outcome meassure, it is determined if there is a correlation between the observed mean fluorescence intensity of a polyp and the VEGF expression in the same polyp, as determined with immunohistochemistry and eventually RNA/DNA analysis. In other words, does the mean fluorescence intensity reflect the VEGF expression of the polyp?

Collection of safety data regarding administration of Bevacizumab-IRDye800CW (adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR)).

The goal of this outcome measure, is to determine the optimal tracer dose (4.5, 10 or 25 mg) of bevacizumab-IRDye800CW for the molecular-guided fluorescence endoscopy procedure to visualize adenomas. The fluorescence intensity of adenomas will be measured in vivo during fluorescence endoscopy and ex vivo (e.g. using confocal fluorescence microscopy, spectroscopy). This will be compared between the three subgroups (patients with different time intervals between tracer injection and endoscopy procedure) to determine the best time interval between tracer injection and endoscopy procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical	NCT02748772	Colorectal Neop...	Two Anti-angiog... Pure chemothera...	18 Years - 75 Years	The First People's Hospital of Hefei
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical	NCT02748772	Colorectal Neop...	Two Anti-angiog... Pure chemothera...	18 Years - 75 Years	The First People's Hospital of Hefei
Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites	NCT00327444	Ovarian Neoplas... Ascites	aflibercept (zi... Placebo aflibercept (zi...	18 Years -	Sanofi
Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW	NCT02113202	Adenomatous Pol...	Bevacizumab-IRD... Near infrared f...	18 Years - 70 Years	University Medical Center Groningen
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical	NCT02748772	Colorectal Neop...	Two Anti-angiog... Pure chemothera...	18 Years - 75 Years	The First People's Hospital of Hefei
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical	NCT02748772	Colorectal Neop...	Two Anti-angiog... Pure chemothera...	18 Years - 75 Years	The First People's Hospital of Hefei
Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites	NCT00327444	Ovarian Neoplas... Ascites	aflibercept (zi... Placebo aflibercept (zi...	18 Years -	Sanofi

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