Anlotinib Plus Penpulimab (AK105) for Chemo-refractory Metastatic Colorectal Cancer:ALTER-C003 (ALTER-C003)
2022년 3월 6일 업데이트: YueJuan Cheng, Peking Union Medical College Hospital
Anlotinib Hydrochloride In Combination With Penpulimab (AK105) in Patients With Chemo-refractory Metastatic Colorectal Cancer, Open, Single Arm,Exploratory Clinical Trial(ALTER-C003)
A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with Penpulimab (AK105) in patients with Chemo-refractory Metastatic Colorectal Cancer (mCRC)
연구 개요
연구 유형
중재적
등록 (예상)
32
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jianfeng Zhou
- 전화번호: 011-86-10-69156114
- 이메일: ZhouJF@pumch.cn
연구 장소
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Beijing, 중국
- 모병
- Peking Union Medical College Hospital
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연락하다:
- jianfeng Zhou
- 이메일: ZhouJF@pumch.cn
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Shenyang, 중국
- 아직 모집하지 않음
- The First Hospital of China Medical University
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연락하다:
- Xiujuan Qu
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Shenyang, 중국
- 아직 모집하지 않음
- The People's Hospital of Liaoning Province
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연락하다:
- Du Zhenguang
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Beijing
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Beijing, Beijing, 중국
- 모병
- Beijing Tiantan Hospital, Capital Medical University
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연락하다:
- Xiaoyuan Li
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수석 연구원:
- Xiaoyuan Li
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Beijing, Beijing, 중국
- 아직 모집하지 않음
- China-Japan Friendship Hospital
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수석 연구원:
- Yuan Li
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연락하다:
- Yuan Li
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Hebei
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Langfang, Hebei, 중국
- 아직 모집하지 않음
- Hebei Petro China Central Hospital
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연락하다:
- Qian Guo
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수석 연구원:
- Qian Guo
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Shijiazhuang, Hebei, 중국
- 아직 모집하지 않음
- The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
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수석 연구원:
- Ruixing Zhang
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연락하다:
- Ruixing Zhang
- 전화번호: 0086-311-86095757
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Tianjin
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Tianjin, Tianjin, 중국
- 모병
- General Hospital of Tianjin Medical University
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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:
- Patients participate in the study voluntarily and sign informed consent with good compliance.
- Be 18 years of age or older on day of signing informed consent.
- Histological or cytological confirmation of Metastatic Colorectal Cancer(T1-4N0-2M1).
- At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1.
- Participants must have received and progressed through or become intolerant to fluoropyrimidine, irinotecan, oxaliplatin, Exceptions may apply.
- Eastern Cooperative Oncology Group Performance Status 0 or 1.
- Life expectancy of at least 3 months.
- Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, leucocyte (WBC) ≥ 3.0×109/L,Platelet count (PLT) ≥ 75×109/L,Total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ×ULN, If liver metastasis is present，ALT and AST<5ULN ；Serum creatinine (Cr) ≤ 1.5× ULN or Creatinine Clearance rate(CCr) ≥60ml/min，Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%)
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.
Exclusion Criteria:
- Histological or cytological confirmation of mucinous adenocarcinoma or ovarian transcoelomic metastasis
- Patients who had previously received treatment with Anlotinib or anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors other immunotherapy against .
- Patients who had previously received treatment within 2 weeks or Participated in other anti-tumor clinical trials within 4 weeks.
- Patients with a large amount of pleural effusion or ascites requiring drainage.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Patients who underwent major surgery within 4 weeks.
- Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
- Patients with a risk of gastrointestinal bleeding may not be enrolled.
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
- Patients with any severe and/or unable to control diseases，including： Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100) mmHg); Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc≥450ms; female QTc≥470ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with interstitial lung disease with symptoms or signs of activity；Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g; Patients with any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, international normalized ratio (INR)>1.5; Patients with a seizure disorder who require pharmacotherapy.
- Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0).
- Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy of prednisone ≥ 10 mg daily or any equivalent dose of corticosteroids.
- Has received a live vaccine or attenuated vaccine within 30 days prior to trial registration.
- Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
- Female patients who are pregnant or breastfeeding.
- Patients with drug abuse history and unable to get rid of or patients with mental disorders.
- Patients who had serious adverse effect to Anlotinib or Penpulimab or any of its excipients
- Known hypersensitivity to other Monoclonal Antibody or any of its excipients.
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Anlotinib+Penpulimab
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Penpulimab 200 mg을 3주마다 정맥주사합니다.
다른 이름들:
12mg, 연속 경구 2주 중단, 1주, 21일 치료 주기.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free survival (PFS)
기간: up to 24 months
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Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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up to 24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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질병 통제율(DCR)
기간: 최대 24개월
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질병 통제율은 RECIST v1.1에 따라 가장 좋은 반응이 CR, PR 또는 안정 질병(SD)인 피험자의 백분율로 정의됩니다.
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최대 24개월
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Objective Response Rate (ORR)
기간: up to 24 months
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Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the RECIST v1.1
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up to 24 months
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Duration of Response (DOR)
기간: up to 24 months
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Duration of Response is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1 or death due to any cause, whichever occurs first.
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up to 24 months
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
기간: Until 30 day safety follow-up visit
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Adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
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Until 30 day safety follow-up visit
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Overall Survival (OS)
기간: Up to 24 months
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Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
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Up to 24 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of TB cells count and interleukin-6/8/10
기간: through study completion, an average of 2 year
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Objectives to analyse the subsets of TB cells and interleukin-6/8/10 associated treatment.
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through study completion, an average of 2 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jianfeng Zhou, Peking Union Medical College Hospital
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)
2021년 11월 5일
기본 완료 (예상)
2022년 8월 23일
연구 완료 (예상)
2023년 8월 23일
연구 등록 날짜
최초 제출
2021년 7월 5일
QC 기준을 충족하는 최초 제출
2021년 7월 13일
처음 게시됨 (실제)
2021년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 3월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 3월 6일
마지막으로 확인됨
2022년 3월 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. .