Dendritic Cell-immunotherapy for Advanced Hepatocellular Carcinoma
A Phase II Trial, Sequential Treatments of Dendritic Cell Vaccination Followed by Transcatheter Arterial Chemoembolization for Advanced Hepatocellular Carcinoma
연구 개요
상세 설명
Hepatocellular carcinoma (HCC) is a high malignant tumor with a rapidly progressive clinical course. Surgery is the first choice of the treatment. However, most HCC patients have numerous tumors upon diagnosis, which are not possible to be treated by surgical resection. Currently, several treatment options are applied to treat unresectable HCC, including transcartheter arterial chemoembolization (TACE), percutaneous ethanol injection, radiofrequency ablation, chemotherapy and radiotherapy. Nevertheless, the therapeutic results of these treatment modalities are unsatisfied.
TACE is frequently applied to treat the patients with unresectable HCCs in daily practice. Embolization blocks the arterial blood supply to the tumor and results in tumor necrosis. However, clinical benefits are limited, and the response rate is only 30% Dendritic cells (DC), the most potent antigen-presenting cells, serve as a cancer vaccine to conduct an antigen-specific anti-tumor therapy. Dendritic cell-based immunotherapy has been applied to treat advanced HCC in our previous study. The clinical results of this study verify the feasibility of DC-based immunotherapy for HCC. However, the results are still unsatisfied.
In this proposal, investigators are going to treatment the patients having unresectable HCCs with DC vaccination followed by TACE. DC vaccination can provoke antigen-specific immunity and induce memory T-cells. TACE following DC vaccination may further promote T-cell immunity to treat cancer. Therefore, the specific aims in this study are:
- To determine whether DC vaccination followed by TACE can treat HCC effectively in a clinical trial.
- To determine whether DC vaccination can provoke memory T cells and following TACE can further promote anti-HCC immunity.
The achievement of this clinical trial will help to establish a new strategy for the treatment of unresectable HCC.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 장소
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Taoyuan, 대만, 33357
- Chang-Gung Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- advanced HCC patients, no response to standard treatment; WBC : 3000-12000/ul; platelet: >80000/ul; anticipated survival > 3 months, measurable tumors.
Exclusion Criteria:
- HIV; BCLC stage; acute infection; sepsis; other advanced malignancy; acute liver failure;
공부 계획
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: dendritic cell treatment
phase 2, one treatment arm
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autologous dendritic cell vaccination
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Treatment-Related Adverse Events
기간: up to 48 months.
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To evaluate the safety of the treatments by assessing the number of participants with treatment-related adverse events.
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up to 48 months.
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Objective Tumor Response
기간: From date of first treatment until the date of first documented progression, assessed up to 48 months.
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To evaluate the tumor responses under the treatments as assessed by modified RECIST criteria.
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From date of first treatment until the date of first documented progression, assessed up to 48 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Survival (OS)
기간: From date of first treatment to death from any cause, assessed up to 48 months.
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To examine the survival of the patients.
Overall survival is defined as the time from the date of first treatment to death from any cause.
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From date of first treatment to death from any cause, assessed up to 48 months.
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Enhancement of Immunity
기간: Baseline and at specified intervals up to 48 months.
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evaluate the enhancement of immunity after treatments by measuring quantitative T-cell proliferation via mixed lymphocyte reaction (MLR).
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Baseline and at specified intervals up to 48 months.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wei-Chen Lee, MD, Chang Gung Memorial Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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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