計劃書編號A-BR-108-087
試驗執行中
2022-06-16 - 2026-12-31
Phase I
召募中1
ICD-10C23
膽囊惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9156.0
膽囊惡性腫瘤
以個人化癌症新抗原為基礎的樹突細胞免疫癌症治療
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試驗申請者
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試驗委託 / 贊助單位名稱
財團法人國家衛生研究院
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臨床試驗規模
台灣單中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
適應症
胰臟癌、肝癌、膽道癌及大腸直腸癌，但不含肉瘤及神經內分泌瘤
試驗目的
1.評估癌症病患進行DCs疫苗治療之安全性。
2.評估癌症病患之腫瘤對於DCs疫苗治療的反應。
3.評估用DCs疫苗治療癌症病患的中位無惡化存活期及整體存活
4.探討癌症病患進行DCs疫苗治療後產生之免疫反應。
5.探討可能之生物標記
藥品名稱
懸液劑
主成份
樹突細胞疫苗
劑型
183
劑量
1.5x10^6 cells/injection
評估指標
依據Response Evaluation Criteria in Solid Tumors (RECIST)標準，個案於完成治療後將每三個月進行一次臨床療效評估，持續追蹤一年後脫離本試驗。
完全緩解(CR)所有可測量的或可評估的腫瘤完全消失
部分緩解(PR)可測量的腫瘤其兩垂直直徑之總合縮小30%或更多
疾病惡化(PD)出現新的病灶或是原腫瘤直徑總合增加20%
穩定疾病(SD)從治療開始以來腫瘤最小的總直徑做為參考，沒有如PR般縮小但也沒如PD般增加
完全緩解(CR)所有可測量的或可評估的腫瘤完全消失
部分緩解(PR)可測量的腫瘤其兩垂直直徑之總合縮小30%或更多
疾病惡化(PD)出現新的病灶或是原腫瘤直徑總合增加20%
穩定疾病(SD)從治療開始以來腫瘤最小的總直徑做為參考，沒有如PR般縮小但也沒如PD般增加
主要納入條件
⚫ ≥20 years of age
⚫ Provide written informed consent
⚫ Histologically confirmed stage IV pancreatic cancer, liver cancer, biliary tract cancer and colorectal cancer (excluding sarcoma and neuroendocrine tumor) that refractory or intolerance to standard therapies for their condition (there is no effective treatment by investigator judgement)
⚫ Completed tumor and germline DNA and RNA sequencing and the neoantigen prediction
⚫ Patients with chronic hepatitis B is eligible if receiving anti-hepatitis B agents and the HBV DNA level < 2000 IU/ml prior to the preparation phase. Patients with chronic hepatitis C are eligible if HCV RNA is undetectable (<15 IU/ml) prior to the preparation phase
⚫ Adequate organ function
◼ Absolute neutrophil count >1000/mcL
◼ Hemoglobin > 8.0 g/dl
◼ Platelet > 50000/mcL
◼ PT/aPTT < 1.5 x upper limit of normal (ULN)
◼ AST/ALT < 3 x ULN or < 5 x ULN in the presence of liver or biliary metastasis
◼ Bil(T) < 1.5 x ULN or < 3 x ULN in the presence of liver or biliary metastasis
◼ BUN/Cr < 1.5 x ULN
⚫ Adequate immune system as defined by
◼ IgG > 614 mg/dl ◼ IgM > 53mg/dl
⚫ Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
⚫ Life expectancy at least>12weeks
⚫ At least one measurable target lesion as defined by RECIST 1.1
⚫ Provide written informed consent
⚫ Histologically confirmed stage IV pancreatic cancer, liver cancer, biliary tract cancer and colorectal cancer (excluding sarcoma and neuroendocrine tumor) that refractory or intolerance to standard therapies for their condition (there is no effective treatment by investigator judgement)
⚫ Completed tumor and germline DNA and RNA sequencing and the neoantigen prediction
⚫ Patients with chronic hepatitis B is eligible if receiving anti-hepatitis B agents and the HBV DNA level < 2000 IU/ml prior to the preparation phase. Patients with chronic hepatitis C are eligible if HCV RNA is undetectable (<15 IU/ml) prior to the preparation phase
⚫ Adequate organ function
◼ Absolute neutrophil count >1000/mcL
◼ Hemoglobin > 8.0 g/dl
◼ Platelet > 50000/mcL
◼ PT/aPTT < 1.5 x upper limit of normal (ULN)
◼ AST/ALT < 3 x ULN or < 5 x ULN in the presence of liver or biliary metastasis
◼ Bil(T) < 1.5 x ULN or < 3 x ULN in the presence of liver or biliary metastasis
◼ BUN/Cr < 1.5 x ULN
⚫ Adequate immune system as defined by
◼ IgG > 614 mg/dl ◼ IgM > 53mg/dl
⚫ Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
⚫ Life expectancy at least>12weeks
⚫ At least one measurable target lesion as defined by RECIST 1.1
主要排除條件
⚫ Sarcoma、neuroendocrine tumor
⚫ Patients who cannot tolerate leukapheresis and follow-up blood sampling of 50ml at day 43, day 85 and end-of- treatment.
⚫ Any known active infection as judged by the investigator
⚫ Any known chronic active infection of HIV, HTLV-1 or HTLV-2
⚫ Requirement of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the screen phase. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active
autoimmune disease.
⚫ Other immunocompromising condition that in the opinion of the treating physician renders the patient a poor candidate for this trial
⚫ Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device (IUD), abstinence, etc.)
⚫ Patients with history of penicillin allergy
⚫ Other medical problems or conditions that, in the opinion of the investigator, would make participation in the study hazardous for the patient
⚫ Patients who cannot tolerate leukapheresis and follow-up blood sampling of 50ml at day 43, day 85 and end-of- treatment.
⚫ Any known active infection as judged by the investigator
⚫ Any known chronic active infection of HIV, HTLV-1 or HTLV-2
⚫ Requirement of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the screen phase. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active
autoimmune disease.
⚫ Other immunocompromising condition that in the opinion of the treating physician renders the patient a poor candidate for this trial
⚫ Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device (IUD), abstinence, etc.)
⚫ Patients with history of penicillin allergy
⚫ Other medical problems or conditions that, in the opinion of the investigator, would make participation in the study hazardous for the patient
試驗計畫預計收納受試者人數
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台灣人數
12 人
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全球人數
0 人
