Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

apatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

apatinib tablet

Jin Li, MD, PHD

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment is still unsatisfied for their toxicity and limitation in prolonging survival. Based on the promising results of apatinib in the phase I study, this clinical trial has been designed to evaluate whether apatinib can improve progression free survival in patients with metastatic gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg qd, one group patients will receive apatinib 425mg bid, and the other group will receive placebo.

Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma

Fudan University

Jin Li/Dr

Symptoms and General Pathology

Disease Progression

Sorafenib

administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent

sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

sorafenib

Jin Li, PhD, M.D.

The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.

Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

Base for drug clinical trials, Fudan University cancer hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Adenocarcinoma

Reproductive Control Agents

Docetaxel

Triptorelin Pamoate

Bicalutamide

Prolactin Release-Inhibiting Factors

Tubulin Modulators

Antimitotic Agents

Hormones

Hormone Antagonists

Docetaxel will be administered:

* To D1 of every cycle in the dose of 70 mg/m²,
* Perfusion IV of 60 minutes diluted in 250 ml with physiological serum or with serum glucoside from a peripheral or central vein, Every 3 weeks during 6 cycles (except when unacceptable tolerance).

Triptorelin was given by injection for 4 times every 3 months Bicalutamide was given at the same time with LH-RH agonist for 3 weeks ; taken orally

Docetaxel + hormonal treatment (LH-RH agonist)

Triptorelin was given by injection for 4 times every 3 months. Bicalutamide given at the same time with LH-RH agonist for 3 weeks ; taken orally.

Hormonal treatment (LH-RH agonist)

Stephane Oudard, MD PhD

The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).

The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total sample size estimated at 252 patients, with a two-sided type I error rate of 5% (non-parametric methods.

Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer (PC) in phase III trials (1-2). It is likely to demonstrate a substantial role in the management of early-stage PC patients in the neoadjuvant and adjuvant settings, where clinical trials are underway.•53% of all men who undergo radical prostatectomy will develop prostate-specific antigen (PSA) elevations in the 10 years following surgery, with approximately 77% of these recurrences occurring within the first 2 years.A prospective, multicenter, national, randomized, two-arm, phase III study comparing hormonal treatment (LH-RH agonist alone) with or without docetaxel was designed to evaluate the interest of chemotherapy in non-metastatic prostate cancer patients at high risk of systemic recurrence after initial treatment (radical prostatectomy or radiotherapy).

1. PETRYLAK DP, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004
2. TANNOCK IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004

A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

ARTIC group (oncologists and urologists association)

Assistance Publique - Hôpitaux de Paris

Aurélie Guimfack

Oxaliplatin

Fluorouracil

Epirubicin

The regimen of 5-day Continuous infusion of FU combined with Epirubicin and Oxaliplatin will be used in the patients recruited in this trial.

epirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, and 5-FU 375-425 mg/m2/d day 1 through 5 continuous infusion, repeated every 3 weeks

EOF5

Jiliang Ying, M.D

The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the approval number was IRB50-15-1101A.

ECF regimen is considered as a reference regimen for gastric cancer in Europe. Now, no regimen has been proved to be more effective while less toxicity than ECF regimen. Oxaliplatin has demonstrated synergy with 5-FU in vitro, in vivo, and in the clinical setting in advanced colorectal cancer. It presents a better toxicity profile than cisplatin. Recently some studies used combination regimens of oxaliplatin, folinic acid, and continuous infusion 5-FU for about 44 hours (e.g FOLFOX4 ) to treat A/MGC, and yielded good response rates and median overall survival times while resulting in lower rates of grade 3-4 adverse events. Therefore, it is logical to modify ECF regimen with oxaliplatin replacing cisplatin and a short-term FU infusion replacing 21-day FU infusion. Our objective is to evaluate whether the EOF5 regimen is less toxicity while is comparable effective as ECF regimen.

Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC

Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer

Patients enrolled in this trial would received 18F-FLT PET SACN and 18F-FDG PET SACN before and 14 days after the first cycle chemotherapy respectively.

associated professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pemetrexed

Cisplatin

Endostatins

Gefitinib

Angiogenesis Inhibitors

Growth Inhibitors

Jianhua Chang, MD,PhD

The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.

Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients

A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Base for drug clinical trials, Fudan University Cancer Hospital

Glioblastoma

Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Neuroepithelioma

Blood sample and life quality questionnaires

Blood will be drawn at distinct time points during and after radio(chemo)therapy

Rainer Fietkau, Prof.

Udo S Gaipl, Prof.

In this explorative study immunological changes during tumor therapy will be analyzed in patients with malignant glioma. Immunophenotyping before and during therapy is used as analysis method. Thereby immune cells are quantitatively and qualitatively detected from patient's blood at continuous time points. Additionally relevant mediators like cytokines, danger signals and chemokines are analyzed by other methods. Obtained results may give information about the effects of therapy on immunological processes and immune cells and may help to find immunological based predictive or prognostic tumor markers and to define time points for including additional immune therapy in the future.

Patients with malignant glioma generally have a bad prognosis. To improve patients' situation new therapy options as well as new possibilities to determine prognosis and prediction more precisely are needed. One approach is the targeted activation of the immune system to recognize and eliminate tumor cells. Due to cerebral tumors the brain is no immune privileged organ anymore, so that immune cells may pass the haemato-encephalic barrier to attack tumor cells. This study aims to offer valuable clues about how the immune system is influenced by standard therapies (radiotherapy and chemotherapy). Just with the background knowledge of immune mechanisms and influencing factors by tumor therapy, an effective anti-tumor response can systematically be induced by modulating immune therapy. To analyze immunological changes, immunophenotyping by flow cytometry is performed with blood from patients with malignant gliomas during their therapy concluding chemoradiation and chemotherapy alone. Count, class and activation status of immune cells are detected by flow cytometry. Together with additional analysis methods, information about immunological mediators like cytokines, chemokines and danger signals can be received. For these purposes serum and plasma are generated from blood samples and stored for prospective questions. The explorative determined results may also help to discover new, immunological based, prognostic or predictive tumor markers.

Immunophenotyping From Blood of Patients With Malignant Gliomas

Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy

Time points for blood sample collections:

Before start of chemoradiation (RCT). In 3th week of RCT. At last day of RCT. At the beginning of chemotherapy (CT) (about 4 weeks after RCT). During CT each three to four weeks. At follow-up visits each one to three months. During recurrence therapy.

Correlation with results of immunophenotyping, possibly definition of medically relevant markers

University of Erlangen-Nürnberg Medical School

Cetuximab

Antineoplastic Agents, Immunological

administer cetuximab in combination with modified FOLFIRI

cetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle

cetuximab

The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.

Study of Cetuximab to Treat Gastric Cancer

Phase II Study of Cetuximab (Erbitux®) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-line Chemotherapy

Micronutrients

Hematinics

Vitamins

Amino Acids

Carboplatin

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w

Cisplatin or carboplatin

Jianhua chang, MD,PHD

The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).

Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

Endostar protein

patients will be treated by ECF regimen (epirubicin, cisplatin plus 5-FU) combined with endostar

Epirubicin 50mg/M2 D1, Cisplatin 60mg/M2 D1, FU 500mg/M2 D1-5, endostar 7.5mg/M2 D1-14, treatment cycle repeat every 3 weeks. Treatment should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

ECF-endostar

Jin Li, PhD, M.D

The purpose of this study is to evaluate the efficacy and tolerability of the ECF regimen (epirubicin, cisplatin and FU) combined with endostar-- a inhibitor of angiogenesis, in patients with advanced or metastatic gastric cancer (A/MGC).

Although there is no standard regimen in the treatment of metastatic gastric cancer, ECF regimen (epirubicin, cisplatin and FU) is often considered as a reference regimen. And ECF regimen has been suggested as the first line therapy for A/MGC by FDA. According to the result of a Chinese phase III clinical trial in metastatic lung cancer, endostar-- a new angiogenesis inhibitor prolonged the overall survival, time to progression and improved response rate. So we designed this clinical trial to evaluate whether endostar can bring survival benefits to patients with advanced and metastatic gastric cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer	NCT00970138	Gastric Carcino...	apatinib tablet	18 Years - 70 Years	Fudan University
Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer	NCT00595985	Gastric Cancer	sorafenib	18 Years - 70 Years	Fudan University
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer	NCT00970138	Gastric Carcino...	apatinib tablet	18 Years - 70 Years	Fudan University
A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel	NCT00764166	Adenocarcinoma ...	Docetaxel + hor... Hormonal treatm...	18 Years -	Assistance Publique - Hôpitaux de Paris
Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC	NCT00767377	Gastric Cancer	EOF5	18 Years - 75 Years	Fudan University
Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients	NCT01192230	Carcinoma, Non-...	Endostatins Docetaxel	18 Years - 80 Years	Fudan University
Immunophenotyping From Blood of Patients With Malignant Gliomas	NCT02022384	Anaplastic Astr... Glioblastoma Mu...	Blood sample an...	18 Years -	University of Erlangen-Nürnberg Medical School
Study of Cetuximab to Treat Gastric Cancer	NCT00699881	Gastric Cancer	cetuximab	18 Years - 70 Years	Fudan University
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer	NCT00970138	Gastric Carcino...	apatinib tablet	18 Years - 70 Years	Fudan University
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients	NCT01192243	Toxicity Non-small Cell ...	Gefitinib Pemetrexed Cisplatin or ca...	18 Years - 70 Years	Fudan University
Epirubicin Cisplatin and Fluorouracil (FU) Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer	NCT00595972	Gastric Cancer	ECF-endostar	18 Years - 70 Years	Fudan University
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients	NCT01192243	Toxicity Non-small Cell ...	Gefitinib Pemetrexed Cisplatin or ca...	18 Years - 70 Years	Fudan University
Study of Cetuximab to Treat Gastric Cancer	NCT00699881	Gastric Cancer	cetuximab	18 Years - 70 Years	Fudan University
Study of Cetuximab to Treat Gastric Cancer	NCT00699881	Gastric Cancer	cetuximab	18 Years - 70 Years	Fudan University

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