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Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer

6 december 2013 bijgewerkt door: Tang Xushan

A Randomized, Open and Control Clinical Study of Endostar Injection Concomitant With SOX Protocols in Treating Advanced Gastric Cancer

The primary objectives of this control, single-center clinical study of EndostarTM Injection with/without SOX protocols to treat advanced gastric cancer were to evaluate the clinical response rate of Endostar injection concomitant with SOX on patients with advanced gastric cancer, observe the progression-free survival time (PFS) of tumor and evaluate the safety and tolerance of Endostar injection, while the secondary objectives were to observe the influence of Endostar injection on chemotherapy-induced adverse reactions and evaluate the overall survival time of EndostarTM injection concomitant with SOX on patients with advanced gastric cancer by evaluating the response rate (RR) clinical benefit rate (CBR), progression-free survival (PFS) and overall survival (OS).

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Multiple pre-clinical studies have indicated that in dozens of animal tumor models and human tumor-metastatic mice tumor models, the effective rate of Endostar was 47%～91% in daily dosage of 10～100mg/kg, and covered human commonly seen malignant tumors, such as lung cancer, gastric cancer, breast cancer, colorectal cancer, hepatic cancer, malignant melanoma and non-Hodgkin's lymphoma, etc.. The development and progression of gastric cancer was in association with angiogenesis. An animal research observed the influence of Endostar on tumor strains in nude mice with gastric cancer, and the results showed that tumor size shrunk rapidly and the expressions of VEGF, bFGF, VEGF-C, VEGFR-3, bcl-2 and PDGF decreased significantly after treatment in experimental group, demonstrating that Endostar could reduce angiogenesis, increase tumor cell apoptosis and inhibit tumor growth in gastric cancer. An investigation of small-sample Endostar concomitant with chemotherapy on patients with advanced gastric cancer primarily indicated the efficacy and feasibility of Endostar concomitant with chemotherapy in treating gastric cancer.

With the expanded application of Endostar in clinic, it also obtains certain effect in treating patients with lung cancer and colorectal cancer. The safety, efficacy, evaluation of relationship between benefit and risk in common or special population as well as the modified dosage of administration of Endostar in wide application should be further explored to provide sufficient scientifical basis for the safety, efficacy, applicable rule in special population and investigation of optimal administrative protocols for Endostar in wide application.

This control, single-center clinical study of EndostarTM Injection with/without SOX protocols to treat advanced gastric cancer was conducted to explore the feasibility, efficacy and safety of Endostar concomitant with SOX protocols, and to provide more evidence-based medical basis for the clinical application of Endostar.

Studietype

Ingrijpend

Inschrijving (Verwacht)

120

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Cancer Hospital of Xinjiang Medical University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age: 18～70 years;
  • Performance status (PS) of Eastern Cooperative Oncology Group (ECOG) was 0～1 or KPS scores were 60-100 scores;
  • Patients who were diagnosed with recurrent and metastatic advanced gastric cancer by histopathology and CT;
  • Patients who had more than 1 measurable nidus (common CT or MRI scanning ≥20 mm, spiral CT scanning ≥10 mm);
  • Patients who had no severe dysfunction of important organs, and were normal in blood routine test, hepatorenal function, electrolytes and cardiac function, with white blood cell count≥4.0×109/L, neutrophil count≥1.5×109/L, platelet count≥100×109/L, hemoglobin≥95g/L, serum bilirubin≤1.5 folds of upper normal limit, Alanine transaminase and glutamic oxalacetic transaminase ≤2 folds of upper normal limit, and serum creatinine≤1.5mg/dl.
  • Estimated survival time was above 3 months;
  • Patients who were well acknowledged of this study and signed the informed consent forms.

Exclusion Criteria:

  • Patients who received whole body treatment of metastatic gastric cancer previously;
  • Patients who underwent surgeries within 4 weeks before this study;
  • Patients who had allergic constitutions or were allergic to biological products of proteins and to any medicine used in this study;
  • Female patients in gestation or lactation period, or those who were interfile but received no contraception measures;
  • Patients who were with other symptoms unsuitable to this study;
  • Patients who were treated by other anti-tumor methods at that time;
  • Patients who had no measurable nidus;
  • Patients who had one of the following conditions: uncontrolled metastatic nidus in central nervous system, dysfunction of important organs, severe cardiac diseases (including congestive heart failure, uncontrollable arrhythmia, angina pectoris needed long-term drug treatment, valvular heart diseases and myocardial infarction), hypertension, women in gestation or lactation period, protracted infectious wound as well as uncontrollable psychosis history.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Oxaliplatin & Endostar injection
Oxaliplatin, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14; Endostar injection, 7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10; 21 d as a cycle.
Geneesmiddel: Oxaliplatin
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Andere namen:
  • L-OHP
Geneesmiddel: Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Andere namen:
  • Tegafur Gimeracil Oteracil Kaliumcapsule
Geneesmiddel: Endostar injection
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
Andere namen:
  • rh-Endostatin
Actieve vergelijker: Oxaliplatin
Oxaliplatin, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Geneesmiddel: Oxaliplatin
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Andere namen:
  • L-OHP
Geneesmiddel: Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Andere namen:
  • Tegafur Gimeracil Oteracil Kaliumcapsule

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Response rate (RR)
Tijdsspanne: The patients were followed up for 3 years.
  • Clinical RR=(CR＋PR)/total cases×100%;
  • Complete remission (CR): all visible nidi disappeared;
  • Partial remission (PR): the decreased total length of diameter of baseline nidus≥30%;
The patients were followed up for 3 years.
clinical benefit rate (CBR)
Tijdsspanne: The patients were followed up for 3 years.
  • Clinical CBR＝(CR＋PR＋SD)/total cases×100%
  • Complete remission (CR): all visible nidi disappeared;
  • Stable disease (SD): the total length of diameter of baseline nidus decreased<that in PR or increased <that in PD.-Progressive disease (PD): the increased total length of diameter of baseline nidus≥30% or new nidus was presented;
The patients were followed up for 3 years.
progression-free survival (PFS)
Tijdsspanne: The patients were followed up for 3 years
PFS was from randomization to tumor progression or death.
The patients were followed up for 3 years

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
overall survival (OS)
Tijdsspanne: The patients were followed up for 3 years
The patients were followed up for 3 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tang Xushan

Onderzoekers

  • Studie directeur: Tang Yong, Professor, Cnacer Hospital of Xinjiang Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2013

Primaire voltooiing (Verwacht)

1 mei 2016

Studie voltooiing (Verwacht)

1 augustus 2016

Studieregistratiedata

Eerst ingediend

27 november 2013

Eerst ingediend dat voldeed aan de QC-criteria

6 december 2013

Eerst geplaatst (Schatting)

11 december 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

11 december 2013

Laatste update ingediend die voldeed aan QC-criteria

6 december 2013

Laatst geverifieerd

1 augustus 2013

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • XinjiangMU (006)

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