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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Changhai Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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This trial is to compare the efficacy and safety of modified FOLFOX6 [mFOLFOX6, a specific chemotherapy regimen of Oxaliplatin ,5-Fluorouracil and Leucovorin] chemotherapy plus Antigen Pulsed Dendritic Cells (APDC,a kind of autologous tumor lysates pulsed human dendritic cells vaccine) with modified chemotherapy alone in patients with metastatic colorectal cancer.
Metastatic colorectal cancer (CRC) patients will be randomly assigned (3:1) to receive either modified FOLFOX6 [mFOLFOX6] chemotherapy combined with Antigen Pulsed Dendritic Cells (Arm APDC + Chemotherapy), or chemotherapy alone (Arm Chemotherapy). Each patient recruited in the study will receive maximum 12 cycles of (14 days/cycle) mFOLFOX6 chemotherapy. Patients in Arm APDC + Chemotherapy will receive APDC vaccination in addition to chemotherapy in the cycle 1-3 and 7-9, and in cycle 4-6 and 10-12 receive only chemotherapy. APDC + Chemotherapy or Chemotherapy will be stopped in case of disease progression, intolerable toxicities, or patient withdrawal with the consent. After 12 cycles, patients in Arm APDC + Chemotherapy will receive 5-Fluorouracil treatment plus every 3 months APDC therapy and patients in Arm Chemotherapy will receive only 5-Fluorouracil treatment. PFS, ORR and OS will be assessed, and toxicity and immunologic effects will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APDC + Chemotherapy | Experimental | Patients in Arm APDC + Chemotherapy will receive APDC combined with chemotherapy. |
|
| Chemotherapy | Active Comparator | Patients in Arm Chemotherapy will receive chemotherapy only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APDC + Chemotherapy | Biological | Patients in Arm APDC+Chemotherapy receive maximum 12 cycles (14days/cycle) mFOLFOX6 chemotherapy. Each cycle chemotherapy consist of Oxaliplatin at 85mg/ m2 infused for 2 hours only on day 1,and Leucovorin at 400 mg/m2 was administered intravenously for 2 hours, followed by continuous intravenous administration of 5-Fluorouracil at 400 mg/m2 (2.4g/m2 for 46 hours).On day 8 of cycle1-3 and 7-9, patients also receive APDC vaccine infusion in 100ml saline. After 12 cycles, patients in Arm APDC+chemotherapy will receive 5-Fluorouracil /Leucovorin (Leucovorin at 400 mg/m2/day administered intravenously for 2 hours, intravenous bolus of 5-Fluorouracil at 400 mg/m2 , followed by continuous intravenous administration of 5-Fluorouracil at 1200 mg/m2/d for 2 days, repeated every 2 weeks) plus APDC therapy (once every 3 months). Treatments will continue unless disease progression, intolerable toxicity or patients withdrawal). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival, PFS | Time from the randomization date to the start of disease progression (progression assessed by investigator using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1 guidelines) for metastatic colorectal cancer subjects. | Up to approximately six years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response | From randomisation to occurrence of objective response( complete regression (CR) and partial regression (PR) need to be confirmed 28 days after the occurrence) | Up to approximately six years |
| Overall Survival, OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Bai, Mastor | Contact | +86 18621696315 | bailan@hisunbio.com | |
| Ke Wang, Bachelor | Contact | +86 13761172785 | wangke@immunol.org |
| Name | Affiliation | Role |
|---|---|---|
| Xuetao Cao, M.D.,Ph.D. | Second Military Medical University | Study Chair |
| Tao Wan, Ph.D. | Second Military Medical University | Study Director |
| Yuankai Shi, M.D.,Ph.D. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Fudan University |
| OTHER |
| Shanghai Changzheng Hospital | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| RenJi Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| First People's Hospital of Hangzhou | OTHER |
| 307 Hospital of PLA | OTHER |
| Huashan Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai Haixin Biotechnology Co. Ltd | UNKNOWN |
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| Chemotherapy | Drug | Patients in Arm Chemotherapy receive maximum 12cycles (14days/cycle) mFOLFOX6 chemotherapy. Each cycle chemotherapy consist of Oxaliplatin at 85mg/ m2 infused for 2 hours only on day 1, and Leucovorin at 400 mg/m2 was administered intravenously for 2 hours, followed by continuous intravenous administration of 5-Fluorouracil at 400 mg/m2 (2.4g/m2 for 46 hours). After 12 cycles, patients in Arm chemotherapy will receive only 5-Fluorouracil /Leucovorin (Leucovorin at 400 mg/m2/day administered intravenously for 2 hours, intravenous bolus of 5-Fluorouracil at 400 mg/m2 , followed by continuous intravenous administration of 5-Fluorouracil at 1200 mg/m2/d for 2 days, repeated every 2 weeks). Treatments will continue unless disease progression, intolerable toxicity or patients withdrawal). |
|
From randomisation to the time of death of any cause.
| Up to approximately six years |
| Clinical benefit Rate | From randomisation to confirmation of objective response | Up to approximately six years |
| Quality of Life | From randomisation to the end of all treatments (according to the EORTC QLQ-C30: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C30) | Up to approximately six months |
| Adverse Events | From randomisation to the end of follow-up | Up to approximately six years |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Principal Investigator |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |