불일치 수리 부족 IIB, IIC 또는 III 결장암에 대한 수술 후 재발을 예방하기위한 면역 요법 (Toripalimab)
불일치 수리 결핍이있는 고위험 국소 대장 암에서 보조제 토리 팔리 맙의 2 상 시험
This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
PRIMARY OBJECTIVE:
I. Evaluate the efficacy of adjuvant toripalimab in patients with resected stage IIB, IIC, and III mismatch repair deficient (dMMR) colon cancer by measuring 3-year disease-free survival.
SECONDARY OBJECTIVES:
I. Define the immune related toxicity profile of toripalimab in the adjuvant setting.
II. Further evaluate the efficacy of adjuvant toripalimab specifically by measuring 3-year relapse free survival (RFS), 5-year disease free survival (DFS), and 5-year overall survival.
TERTIARY/EXPLORATORY OBJECTIVES:
I. To explore immune, ctDNA, and omic markers associated with clinical efficacy (DFS).
II. To assess patient reported outcomes (PRO) and health related quality of life (QoL).
OUTLINE:
Eligible consenting participants will receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months until 5 years post-resection. After completion of study medication, participants undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. Patient reported outcomes and quality of life will also be assessed with questionnaires.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Oluwadunni E. Emiloju, MBBS, MS
- 전화번호: 404-778-1900
- 이메일: oluwadunni.eunice.emiloju@emory.edu
연구 연락처 백업
- 이름: Olatunji B. Alese, MD, FASCO
- 이메일: olatunji.alese@emory.edu
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30322
- 모병
- Emory University Hospital/Winship Cancer Institute
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수석 연구원:
- Oluwadunni E. Emiloju, MBBS, MS
-
연락하다:
- Tyler Whitfield
- 전화번호: 404-778-1900
- 이메일: tyler.stephen.whitfield@emory.edu
-
Atlanta, Georgia, 미국, 30308
- 모병
- Emory University Hospital Midtown
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연락하다:
- Jalpa Patel
- 이메일: jalpa.r.patel@emory.edu
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수석 연구원:
- Oluwadunni E. Emiloju, MBBS, MS
-
Atlanta, Georgia, 미국, 30342
- 모병
- Emory Saint Joseph's Hospital
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수석 연구원:
- Oluwadunni E. Emiloju, MBBS, MS
-
연락하다:
- Ainsley Hymel
- 이메일: ainsley.hymel@emory.edu
-
Atlanta, Georgia, 미국, 30033
- 모병
- Emory Decatur Hospital
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수석 연구원:
- Oluwadunni Emiloju
-
연락하다:
- Kathleen Coleman
- 전화번호: 404-778-1900
- 이메일: kmcole5@emory.edu
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Johns Creek, Georgia, 미국, 30097
- 모병
- Emory Johns Creek Hospital
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수석 연구원:
- Oluwadunni E. Emiloju, MBBS, MS
-
연락하다:
- Hafsa Ahmed
- 이메일: hafsa.maheen.ahmed@emory.edu
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer [AJCC] 8)
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Deficient mismatch repair (MMR) by immunohistochemistry or microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS)
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Complete (R0) resection of pathologic stage IIB, IIC and III dMMR colon cancer 4 to 12 weeks prior to first dose of study drug
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Available tissue sample from surgical specimen
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Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
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Absolute neutrophil count (ANC) ≥ 1,000 /mcL
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Platelets ≥ 75,000 / mcL
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Hemoglobin ≥ 9 g/dL or ≥ 5.0 mmol/L
- Transfusion is allowed to obtain an adequate hemoglobin level
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Creatinine ≤ 1.5 x upper limit of normal (ULN) or measured or calculated creatinine clearance ≥ 40 mL/min for patient with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl])
- Creatinine clearance should be calculated per institutional standard
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Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN
- Patients with previously diagnosed Gilbert syndrome can have total bilirubin < 3.0 mg/dL
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Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x ULN
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Alkaline phosphatase ≤ 3 x ULN
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Signed informed consent
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Patients at least 18 years of age
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Colonoscopy should be performed before surgery and if synchronous colon cancers are present, both must have deficient MMR and both must have undergone complete resection for patient to be eligible. If colonoscopy was not done pre-operatively, the patient may still be eligible if all other inclusion criteria are met. It should however be performed within 6 months after initial colon resection surgery
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Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP are women younger than 55 years (yrs) of age excluding those who are surgically unable to get pregnant due to prior hysterectomy and or bilateral salpingo-oophorectomy
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Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 90 days after the last dose of study drug. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard
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Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 90 days after the last dose of study drug
Exclusion Criteria:
- Neoadjuvant treatment for dMMR colon cancer
- Presence of metastatic dMMR colon cancer
- Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
- Uncontrolled psychiatric illness or psychological condition potentially hampering compliance with the study protocol and follow-up schedule
- History of pneumonitis requiring treatment with steroids, or history of interstitial lung disease
- History of prior malignancy other than the cancer under study, that is progressing or has required active treatment within the past 3 years. Exceptions include adequately treated basal cell or squamous cell carcinoma of skin, superficial bladder cancer, in situ cervical cancer, in situ breast cancer, other in situ cancers, prostate cancer with a Gleason score ≤6 that does not need therapy or other local tumors that are considered cured.
- Autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo, diabetes mellitus type 1, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, controlled psoriasis or resolved childhood asthma/atopy not requiring systemic treatment can be enrolled
- Active hepatitis B or hepatitis C
- Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Treatment with live vaccines within 30 days prior to the first dose of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, nasal seasonal flu, H1N1 flu, rabies, Bacille Calmette Guerin (BCG) and typhoid vaccine
- Prior treatment with any immune checkpoint inhibitor
- Current pregnancy or breastfeeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Treatment (toripalimab)
Eligible consenting participants receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. Following this, patients undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. For patients who have a recurrence, a biopsy will be performed at the time of recurrence. |
Undergo CT
다른 이름들:
Ancillary studies Undergo biopsy
다른 이름들:
Undergo collection of blood samples
다른 이름들:
Undergo colonoscopy Given IV
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
3-year Disease free survival (DFS)
기간: Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years
|
Time between the date of registration and the first date of documented recurrence, regardless of discontinuation of study drug, or death due to any cause, assessed at 3 years |
Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of treatment-related adverse events
기간: Up to 5 years
|
Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Treatment-related adverse events (defined as potentially, probably and definitely) will be summarized in preferred term by system organ class and listed on an individual subject basis at patient level. Immune-related adverse events will also be tabulated. |
Up to 5 years
|
|
3-year Relapse free survival (RFS)
기간: Time between the date of registration and the first date of documented disease recurrence assessed up to 3 years.
|
Time between the date of registration and the first date of documented disease recurrence, assessed at 3 years |
Time between the date of registration and the first date of documented disease recurrence assessed up to 3 years.
|
|
5-year DFS
기간: Time between the date of registration and the first date of documented recurrence, or death due to any cause assessed up to 5 years
|
Time between the date of registration and the first date of documented recurrence, regardless of discontinuation of study drug, or death due to any cause, assessed at 5 years. |
Time between the date of registration and the first date of documented recurrence, or death due to any cause assessed up to 5 years
|
|
Colon cancer specific survival (CCSC)
기간: Time between the date of registration and the date of death due to colon cancer, assessed up to 5 years
|
CCSC is the time between the date of registration and the date of death due to colon cancer, assessed up to 5 years |
Time between the date of registration and the date of death due to colon cancer, assessed up to 5 years
|
|
Overall survival (OS)
기간: Time between the date of registration and the date of death due to any cause, assessed up to 5 years
|
Time between the date of registration and the date of death due to any cause. |
Time between the date of registration and the date of death due to any cause, assessed up to 5 years
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Oluwadunni E. Emiloju, MBBS, MS, Emory University Hospital/Winship Cancer Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- STUDY00008833
- P30CA138292 (미국 NIH 보조금/계약)
- STUDY00008833 (기타 식별자: Emory University Hospital/Winship Cancer Institute)
- NCI-2025-05423 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- WINSHIP6483-24 (기타 식별자: Emory University Hospital/Winship Cancer Institute)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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