A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer
2026년 5월 19일 업데이트: Changchun GeneScience Pharmaceutical Co., Ltd.
An Multi-center, Open-label Phase Ib/II Study of Gentuximab Injection + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer to Evaluate Tolerability, Safety, Efficacy and Pharmacokinetics.
The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study.
Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
연구 개요
상세 설명
The study includes dose-limiting toxicity （DLT）observing period and randomization period with two cohorts as low-dose group（Gentuximab Injection 8mg/kg+ paclitaxel） and high-dose group（Gentuximab Injection 12mg/kg+ paclitaxel）.
During the study，the anti-cancer efficacy, safety and anti-drug antibody were evaluated in all patients.
DLT observation is only to subjects enrolled in DLT observation period and it lasts one treatment period.
PK were doing in part of subjects.
연구 유형
중재적
등록 (실제)
76
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Shanghai, 중국
- Shanghai First People's Hospital
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Shanghai, 중국
- Shanghai East Hospital
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Fujian
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Fuzhou, Fujian, 중국
- Fujian Tumor Hospital
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Guangdong
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Guangzhou, Guangdong, 중국
- The Sixth Hospital of Sun Yat-sen University
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Heilongjiang
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Harbin, Heilongjiang, 중국
- The Affiliated Tumor Hospital of Harbin Medical University
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Henan
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Zhengzhou, Henan, 중국
- the First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, 중국
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, 중국
- Jiangsu Province Hospital
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Jilin
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Changchun, Jilin, 중국
- The First Hospital of Jilin University
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Zhejiang
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Hangzhou, Zhejiang, 중국
- The First Affiliated Hospital, Zhejiang University School of Medicine
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Hangzhou, Zhejiang, 중국
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Hangzhou, Zhejiang, 중국
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent.
- Male or female. aged between 18 and 75 years
- Histopathologically confirmed advanced advanced gastric or gastroesophageal junction cancer, and Documented progression during first-line fluoropyrimidine- and platinum- containing chemotherapy, or during the 3 months following the last cycle of such chemotherapy (or during the 6 months following the last dose of adjuvant therapy or new adjuvant therapy containing fluoropyrimidine and platinium).
- At least one Measurable lesion.
- ECOG Performance status (PS) score, 0-1 level.
- A life expectancy of >3 months.
- Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin concentration ≥90g/L (allowing blood transfusion); and platelet count ≥80×109/L.
- Adequate hepatic function, as defined by: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (liver metastases patients ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN).
- Adequate renal function, as defined by: serum creatinine level≤ 1.5 × ULN, or creatinine clearance ≥ 50ml / min when serum creatinine level> 1.5 × ULN.
- Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5× ULN, activated partial thromboplastin time (aPTT) ≤1.5 x ULN.
- 24-hour urine protein quantitation is <1g（24-hour urine protein quantitative test should be performed when urine protein ≥1+ is found during screening visit）.
- Subjects (male and female) who have fertility must agree to use reliable contraceptive methods during the trial and in 3 months after the last administration. Female subjects in childbearing age must be negative for blood pregnancy test prior to enrollment.
Exclusion Criteria:
- Previously administrated with anti-angiogenic drugs or paclitaxel.
- Systematic anti-tumor therapy (non-anti-angiogenic drugs or paclitaxel) such as chemotherapy, radiotherapy, macromolecular targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks before the first dose of investigational drug, except for the following: nitrourea or mitomycin C is within 6 weeks before the first dose, oral fluorouracil and small molecule targeted drugs are within 2 weeks or 5 half-life of the drug(whichever is longer) before the first dose，Chinese medicine with anti-cancer indications is within 2 weeks before the first dose.
- Has participated in a clinical study of a non-approved experimental agent within 4 weeks prior to screening visit.
- Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy)， or would undergo planned surgery during the study.
- Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA > ULN.
- Patients with previously confirmed malignant tumors.
- History of arterial thrombosis or deep vein thrombosis within 6 months prior to screening, or a bleeding event no less than Grade level 3 within 2 months prior to screening， or the investigator determines that there is a risk of bleeding.
- History of severe cardiovascular and cerebrovascular diseases.
- Subjects with confirmed brain tumor metastases，but subjects in steady situation can be enrolled.
- Active bleeding confirmed by gastroscopy when fecal occult blood positive (only subjects with primary lesions not removed need to do fecal occult blood test.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 12 months before screening visit.
- Thoracic，abdominal or pericardial effusion that cannot be controlled by repeated drainage or with obvious symptoms.
- Has a nonhealing wound, serious ulcer, or unrecovered bone fracture.
- Active infections requiring systemic treatment, including but not limited to active tuberculosis.
- Using anticoagulation and antiplatelet drugs.
- Female subjects who is pregnant (confirmed by urine or serum pregnancy test) or lactating.
- Has a known serious allergy reaction to recombination monoclonal antibody (MAb) drug, ,or infusion reaction.
- Has known alcohol or drug dependency.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: 1 Gentuximab+ Paclitaxel
8 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15
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Administered intravenously (IV)
정맥 내 투여 (IV)
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실험적: 2 Gentuximab+ Paclitaxel
12 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15
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Administered intravenously (IV)
정맥 내 투여 (IV)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Dose-limiting toxicities (DLT)
기간: Up to 4 Weeks
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Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol
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Up to 4 Weeks
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AEs or SAEs
기간: Baseline through Study Completion, about 24 weeks
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Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
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Baseline through Study Completion, about 24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective response rate（ORR）
기간: Up to 6 cycles (28 days for every cycle)
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Proportion of Participants With CR and PR
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Up to 6 cycles (28 days for every cycle)
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Progression-free survival (PFS)
기간: Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient tumor progression or death.
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Up to 6 cycles (28 days for every cycle)
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Disease control rate (DCR)
기간: Up to 6 cycles (28 days for every cycle)
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Proportion of Participants With CR, PR and SD
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Up to 6 cycles (28 days for every cycle)
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Time-to-progress (TTP)
기간: Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient tumor progression.
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Up to 6 cycles (28 days for every cycle)
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Time-to-failure (TTF)
기간: Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient withdraw from the study.
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Up to 6 cycles (28 days for every cycle)
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Anti-drug antibody
기간: Up to 6 cycles (28 days for every cycle)
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Number of Participants With Anti-drug Antibodies
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Up to 6 cycles (28 days for every cycle)
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Pharmacokinetics Cmax
기간: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
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Maximum Concentration (Cmax)
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Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
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Area Under the Concentration-Time Curve (AUC)
기간: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) （28 days for every cycle）
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Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) （28 days for every cycle）
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 11월 5일
기본 완료 (실제)
2020년 6월 1일
연구 완료 (실제)
2020년 9월 20일
연구 등록 날짜
최초 제출
2019년 7월 27일
QC 기준을 충족하는 최초 제출
2019년 8월 9일
처음 게시됨 (실제)
2019년 8월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 19일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- GenSci 043 CT
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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