- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05029453
Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy
2021년 8월 26일 업데이트: Tao Zhang, Wuhan Union Hospital, China
A Prospective, Multicenter, Randomized Controlled Study of Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy
The study is a multicenter, open-label, randomized controlled clinical study.
The purpose of the study is to evaluate the efficacy and safety of apatinib combined with chemotherapy versus chemotherapy in second-line gastric cancer receiving prior anti-PD-1 therapy.
연구 개요
상세 설명
60 patients who meet the inclusion criteria will receive apatinib combine with chemotherapy or chemotherapy until the disease progresses or intolerable.
Apatinib: initial dose: 500mg,oral,once a day, after meal (try to take the medicine at the same time each day)
연구 유형
중재적
등록 (예상)
60
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Tao Zhang, Doctor
- 전화번호: (+86)18971656660
- 이메일: 1277577866@qq.com
연구 장소
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Hubei
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Wuhan, Hubei, 중국, 430022
- Cancer Center, Union Hospital, 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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age: ≥18 years old, Female or Male;
- Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
- Failure or intolerance of first-line chemotherapy which requires that the first-line chemotherapy regimen include the scheme based on anti-PD-1 drugs for no less than 2 months (Definition of treatment failure: intolerence of toxic side effects; disease progression during treatment; Or recurrence after the end of treatment.) Note: (1)The treatment of each line advanced disease includes one or more drugs with a medication time ≥ 1 cycle. (2) Early adjuvant/neo-adjuvant therapy is allowed. If recurrence occurs during adjuvant/neoadjuvant therapy or within ≤24 weeks after completion, adjuvant/neoadjuvant therapy is considered to be a first-line pre-systemic chemotherapy for advanced disease. (3) Early-stage immunotherapy, combined chemotherapy or combined targeted drugs are allowed (except for VEGFR inhibitors).
- Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria
- ECOG performance status 0-1.
- An expected survival of > 12 weeks.
- Has adequate sufficient organ and bone marrow functions.
- Patients whose adverse events caused by previous treatment have recovered to <= CTCAE 1 degree; And the interval between receiving nitroso or mitomycin ≥6 weeks; Receiving other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has healed completely.
- Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug
- Patients have agreed and signed the informed consent. Willingness and able to follow the planned visit, research treatment, laboratory examination and other test procedures.
Exclusion Criteria:
- It is known that it's allergic to any test drug and its excipients.
- Previously received anti-angiogenic therapy, such as Ramucirumab and apatinib.
- patients with uncontrolled large amount of exudate [chest, pericardium, abdominal cavity]
- Patients with partial or complete gastrointestinal obstruction.
- Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- Patients with uncontrolled clinical symptoms or diseases of the heart.
- In the first 3 months of the study, patients who had significant clinical bleeding symptoms or had definite bleeding tendency; History of gastrointestinal perforation and/or fistulae within 6 months prior to medications.
- Long term use of aspirin, clopidogrel and other antiplatelet drugs, or warfarin and other anticoagulants;
- Received other therapy within 4 weeks.
- The patients who received systemic treatment with Chinese herbal medicine or immunomodulatory drugs
- According to the research's judgement, there are patients who seriously endanger the safety of patients or affect the patients who complete.(such as uncontrolled hypertension、diabetes、thyroid disease, etc)
- The patient has a serious or non healing wound or peptic ulcer or bone fracture;
- A patient with other malignancies within 3 years.
- patients whose adverse events (except hair loss) caused by previous treatment have not recovered to <= CTCAE 1 degree;
- The researchers considered unsuitable for inclusion.
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: Experimental Group
apatinib combine with chemotherapy.
Apatinib: initial dose: 500mg,oral,once a day, after meal ( try to take the medicine at the same time each day) Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。
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In experimental group, the drug used with apatinib and chemotherapy.
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간섭 없음: Control Gtoup
chemotherapy Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression Free Survival [PFS]
기간: 36 months
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
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36 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective tumor response rate [ORR]
기간: 1year
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ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
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1year
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disease control rate [DCR]
기간: 1year
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Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1)
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1year
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Duration of response [DoR]
기간: 1year
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Duration of response
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1year
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overall survival [OS]
기간: 3year
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OS is defined as the length of time from random assignment to death or to last contact.
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3year
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Adverse Events [AEs]
기간: 1year
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AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
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1year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Tao Zhang, Doctor, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
- Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.
- Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
- Schvartsman G, Peng SA, Bis G, Lee JJ, Benveniste MFK, Zhang J, Roarty EB, Lacerda L, Swisher S, Heymach JV, Fossella FV, William WN. Response rates to single-agent chemotherapy after exposure to immune checkpoint inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2017 Oct;112:90-95. doi: 10.1016/j.lungcan.2017.07.034. Epub 2017 Aug 3.
- Park SE, Lee SH, Ahn JS, Ahn MJ, Park K, Sun JM. Increased Response Rates to Salvage Chemotherapy Administered after PD-1/PD-L1 Inhibitors in Patients with Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Jan;13(1):106-111. doi: 10.1016/j.jtho.2017.10.011. Epub 2017 Oct 31.
- Cancer Genome Atlas Research Network. Comprehensive molecular characterization of gastric adenocarcinoma. Nature. 2014 Sep 11;513(7517):202-9. doi: 10.1038/nature13480. Epub 2014 Jul 23.
- Shi Q, de Gramont A, Grothey A, Zalcberg J, Chibaudel B, Schmoll HJ, Seymour MT, Adams R, Saltz L, Goldberg RM, Punt CJ, Douillard JY, Hoff PM, Hecht JR, Hurwitz H, Diaz-Rubio E, Porschen R, Tebbutt NC, Fuchs C, Souglakos J, Falcone A, Tournigand C, Kabbinavar FF, Heinemann V, Van Cutsem E, Bokemeyer C, Buyse M, Sargent DJ. Individual patient data analysis of progression-free survival versus overall survival as a first-line end point for metastatic colorectal cancer in modern randomized trials: findings from the analysis and research in cancers of the digestive system database. J Clin Oncol. 2015 Jan 1;33(1):22-8. doi: 10.1200/JCO.2014.56.5887. Epub 2014 Nov 10.
- Salati M, Di Emidio K, Tarantino V, Cascinu S. Second-line treatments: moving towards an opportunity to improve survival in advanced gastric cancer? ESMO Open. 2017 Jul 19;2(3):e000206. doi: 10.1136/esmoopen-2017-000206. eCollection 2017.
- Yan Y, Cao S, Liu X, Harrington SM, Bindeman WE, Adjei AA, Jang JS, Jen J, Li Y, Chanana P, Mansfield AS, Park SS, Markovic SN, Dronca RS, Dong H. CX3CR1 identifies PD-1 therapy-responsive CD8+ T cells that withstand chemotherapy during cancer chemoimmunotherapy. JCI Insight. 2018 Apr 19;3(8):e97828. doi: 10.1172/jci.insight.97828. eCollection 2018 Apr 19.
- Shiono A, Kaira K, Mouri A, Yamaguchi O, Hashimoto K, Uchida T, Miura Y, Nishihara F, Murayama Y, Kobayashi K, Kagamu H. Improved efficacy of ramucirumab plus docetaxel after nivolumab failure in previously treated non-small cell lung cancer patients. Thorac Cancer. 2019 Apr;10(4):775-781. doi: 10.1111/1759-7714.12998. Epub 2019 Feb 27.
- Harada D, Takata K, Mori S, Kozuki T, Takechi Y, Moriki S, Asakura Y, Ohno T, Nogami N. Previous Immune Checkpoint Inhibitor Treatment to Increase the Efficacy of Docetaxel and Ramucirumab Combination Chemotherapy. Anticancer Res. 2019 Sep;39(9):4987-4993. doi: 10.21873/anticanres.13688.
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 (예상)
2021년 8월 26일
기본 완료 (예상)
2022년 12월 31일
연구 완료 (예상)
2023년 3월 3일
연구 등록 날짜
최초 제출
2021년 8월 26일
QC 기준을 충족하는 최초 제출
2021년 8월 26일
처음 게시됨 (실제)
2021년 8월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 8월 26일
마지막으로 확인됨
2021년 8월 1일
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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Apatinib에 대한 임상 시험
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Linhui Peng모병
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First Affiliated Hospital of Chongqing Medical...아직 모집하지 않음면역 조절 | 간세포 암종 | 면역요법에 대한 저항성 | 약물 재창출중국
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Sun Yat-sen UniversityJiangsu HengRui Medicine Co., Ltd.모병
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Peking Union Medical College Hospital완전한
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Sun Yat-sen UniversityJiangsu Hengrui Pharmaceutical Co., Ltd.완전한
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Tianjin Medical University Cancer Institute and...알려지지 않은
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Peking University Cancer Hospital & InstitutePeking University First Hospital; Shanxi Province Cancer Hospital; Peking University Third... 그리고 다른 협력자들완전한
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Tianjin Medical University Cancer Institute and...Zhejiang Cancer Hospital; Fudan University; Liaoning Tumor Hospital & Institute; Gansu Cancer...알려지지 않은
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Tianjin Medical University Cancer Institute and...알려지지 않은