Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer
A Randomized, Open and Control Clinical Study of Endostar Injection Concomitant With SOX Protocols in Treating Advanced Gastric Cancer
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Xinjiang
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Urumqi, Xinjiang, 중국, 830011
- Cancer Hospital of Xinjiang Medical University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
다른 이름들:
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
다른 이름들:
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
다른 이름들:
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활성 비교기: 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.
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130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
다른 이름들:
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Response rate (RR)
기간: The patients were followed up for 3 years.
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The patients were followed up for 3 years.
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clinical benefit rate (CBR)
기간: The patients were followed up for 3 years.
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The patients were followed up for 3 years.
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progression-free survival (PFS)
기간: The patients were followed up for 3 years
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PFS was from randomization to tumor progression or death.
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The patients were followed up for 3 years
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2차 결과 측정
결과 측정 |
기간 |
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overall survival (OS)
기간: The patients were followed up for 3 years
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The patients were followed up for 3 years
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Tang Yong, Professor, Cnacer Hospital of Xinjiang Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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