Metastatic Colorectal CancerPhase 3NCT02503150
Trial of Antigen Pulsed Dendritic Cells (APDC) in Metastatic Colorectal Cancer
A Phase 3 study testing APDC + Chemotherapy and Chemotherapy in people with Metastatic Colorectal Cancer, run by Second Military Medical University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- APDC + Chemotherapy and Chemotherapy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the colorectum with metastatic lesions and received no previous therapy for metastatic lesions;
- Be able to undergo surgical resection to obtain at least 1cm3 tumor tissues;
- The patients are from 18-75 years old regardless of gender;
- An estimated life expectancy of more than 6 months with ECOG≤2;
- Adequate hepatic, renal, and bone marrow functions: neutrophilic granulocyte≥1.5×109/L, Hb(hemoglobin)≥90g/L, PLT(platelets)≥100×109/L, serum Cr(creatinine)≤1.5-time upper normal limit, serum TBIL(total bilirubin)≤1.5-time upper normal limit, both serum ALT and AST(alanine aminotransferase and aspartate aminotransferase)≤2.5-time upper normal limit, hepatic metastases CRC patients' serum ALT/AST≤5-time upper normal limit;
- At least one measurable lesion after surgical resection (According to the standard of RECIST1.1 version: Response Evaluation Criteria in Solid Tumors 1.1 version);
- Written informed consent.
Who cannot join
- Severe (ie, active) heart disease, such as coronary heart disease symptoms, the New York Heart Association (NYHA) II-class or more serious congestive heart failure or severe arrhythmia requiring medication intervention, or history of myocardial infarction within the last 12 months; severe pulmonary dysfunction; peripheral neuropathy; unstable hypertension;
- Metastases lesions> 50% of liver volume;
- Autoimmune diseases, organ transplantation requiring immunosuppressive therapy and patients requiring long-term systemic corticosteroid therapy;
- History of other malignant diseases (except cured basal cell carcinoma and cervical carcinoma in situ) in the last 5 years;
- Pregnant or lactating women (women at childbearing age in the baseline pregnancy test positive or pregnancy test not examined. Menopausal women have menopause at least 12 months);
- Acute or chronic infectious diseases in active phase; severe uncontrolled infection, or other serious uncontrolled concomitant diseases;
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- Definite history of allergy or allergic constitutions;
- Chemotherapy, radiotherapy or immunotherapy within four weeks;
- Administration of other investigational drugs or procedures within four weeks.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase III Trial of Antigen Pulsed Dendritic Cells (APDC) Combined With Chemotherapy in Metastatic Colorectal Cancer
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.
Read the detailed description
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- APDC + Chemotherapy, Chemotherapy
- Keywords
- Colorectal Cancer, Tumor Therapeutic Vaccine, Dendritic Cell
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APDC + ChemotherapyBiological
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).
ChemotherapyDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| APDC + Chemotherapy | Experimental | Patients in Arm APDC + Chemotherapy will receive APDC combined with chemotherapy. Receives: Biological: APDC + Chemotherapy |
| Chemotherapy | Active comparator | Patients in Arm Chemotherapy will receive chemotherapy only. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately six years
Secondary outcomes (5)
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)
Measured: Up to approximately six years
Overall Survival, OS
From randomisation to the time of death of any cause.
Measured: Up to approximately six years
Clinical benefit Rate
From randomisation to confirmation of objective response
Measured: 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)
Measured: Up to approximately six months
Adverse Events
From randomisation to the end of follow-up
Measured: Up to approximately six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Changhai Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University, Shanghai Changzheng Hospital, Zhejiang Cancer Hospital, Chinese PLA General Hospital, Peking University Cancer Hospital & Institute, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, First People's Hospital of Hangzhou, 307 Hospital of PLA, Huashan Hospital, Ruijin Hospital, Shanghai Haixin Biotechnology Co. Ltd
- Responsible party
- Sponsor
- Investigators
- Xuetao Cao, M.D.,Ph.D., Study chair, Second Military Medical UniversityTao Wan, Ph.D., Study director, Second Military Medical UniversityYuankai Shi, M.D.,Ph.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503150
- Sponsor's protocol ID
- SMMU, Shanghai
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Antigen Pulsed Dendritic Cells (APDC) Combined With Chemotherapy in Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02503150
- Acronym / sponsor ID
- SMMU, Shanghai
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal Cancer, Tumor Therapeutic Vaccine, Dendritic Cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Changhai Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University, Shanghai Changzheng Hospital, Zhejiang Cancer Hospital, Chinese PLA General Hospital, Peking University Cancer Hospital & Institute, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, First People's Hospital of Hangzhou, 307 Hospital of PLA, Huashan Hospital, Ruijin Hospital, Shanghai Haixin Biotechnology Co. Ltd
- Study start
- Jul 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APDC + Chemotherapy | Experimental | Biological: APDC + ChemotherapyPatients in Arm APDC + Chemotherapy will receive APDC combined with chemotherapy. |
| Chemotherapy | Active comparator | Drug: ChemotherapyPatients in Arm Chemotherapy will receive chemotherapy only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma of the colorectum with metastatic lesions and received no previous therapy for metastatic lesions;
- Be able to undergo surgical resection to obtain at least 1cm3 tumor tissues;
- The patients are from 18-75 years old regardless of gender;
- An estimated life expectancy of more than 6 months with ECOG≤2;
- Adequate hepatic, renal, and bone marrow functions: neutrophilic granulocyte≥1.5×109/L, Hb(hemoglobin)≥90g/L, PLT(platelets)≥100×109/L, serum Cr(creatinine)≤1.5-time upper normal limit, serum TBIL(total bilirubin)≤1.5-time upper normal limit, both serum ALT and AST(alanine aminotransferase and aspartate aminotransferase)≤2.5-time upper normal limit, hepatic metastases CRC patients' serum ALT/AST≤5-time upper normal limit;
Key exclusion criteria (9 listed)
- Severe (ie, active) heart disease, such as coronary heart disease symptoms, the New York Heart Association (NYHA) II-class or more serious congestive heart failure or severe arrhythmia requiring medication intervention, or history of myocardial infarction within the last 12 months; severe pulmonary dysfunction; peripheral neuropathy; unstable hypertension;
- Metastases lesions> 50% of liver volume;
- Autoimmune diseases, organ transplantation requiring immunosuppressive therapy and patients requiring long-term systemic corticosteroid therapy;
- History of other malignant diseases (except cured basal cell carcinoma and cervical carcinoma in situ) in the last 5 years;
- Pregnant or lactating women (women at childbearing age in the baseline pregnancy test positive or pregnancy test not examined. Menopausal women have menopause at least 12 months);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APDC + ChemotherapyPatients 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). | Biological | APDC + Chemotherapy |
| ChemotherapyPatients 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). | Drug | Chemotherapy |
Primary outcome
Progression Free Survival, PFS
Time frame: Up to approximately six years
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.
5 secondary outcomes
Objective Response
Time frame: Up to approximately six years
Overall Survival, OS
Time frame: Up to approximately six years
Clinical benefit Rate
Time frame: Up to approximately six years
Quality of Life
Time frame: Up to approximately six months
Adverse Events
Time frame: Up to approximately six years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuetao Cao, M.D.,Ph.D. study chair
Second Military Medical University
Tao Wan, Ph.D. study director
Second Military Medical University
Yuankai Shi, M.D.,Ph.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APDC + Chemotherapy and Chemotherapy in people with Metastatic Colorectal Cancer, run by Second Military Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan Bai, Mastor (+86 18621696315, bailan@hisunbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival, PFS (time frame: Up to approximately six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.