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Trial of Antigen Pulsed Dendritic Cells (APDC) in Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

APDC + Chemotherapy

Chemotherapy

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Colorectal Cancer, Tumor Therapeutic Vaccine, Dendritic Cell

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
Definite history of allergy or allergic constitutions;
Chemotherapy, radiotherapy or immunotherapy within four weeks;
Administration of other investigational drugs or procedures within four weeks.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

APDC + Chemotherapy

Chemotherapy

Arm Description

Patients in Arm APDC + Chemotherapy will receive APDC combined with chemotherapy.

Patients in Arm Chemotherapy will receive chemotherapy only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Overall Survival, OS

From randomisation to the time of death of any cause.

Clinical benefit Rate

From randomisation to confirmation of objective response

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)

Adverse Events

From randomisation to the end of follow-up

Full Information

NCT ID

NCT02503150

First Posted

July 16, 2015

Last Updated

July 29, 2015

Sponsor

Second Military Medical University

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, School of Medicine, Zhejiang University, First People's Hospital of Hangzhou, 307 Hospital of PLA, Huashan Hospital, Ruijin Hospital, Shanghai Haixin Biotechnology Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02503150

Brief Title

Trial of Antigen Pulsed Dendritic Cells (APDC) in Metastatic Colorectal Cancer

Official Title

Phase III Trial of Antigen Pulsed Dendritic Cells (APDC) Combined With Chemotherapy in Metastatic Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Military Medical University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

Colorectal Cancer, Tumor Therapeutic Vaccine, Dendritic Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

APDC + Chemotherapy

Arm Type

Experimental

Arm Description

Patients in Arm APDC + Chemotherapy will receive APDC combined with chemotherapy.

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

Patients in Arm Chemotherapy will receive chemotherapy only.

Intervention Type

Biological

Intervention Name(s)

APDC + Chemotherapy

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

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).

Primary Outcome Measure Information:

Title

Progression Free Survival, PFS

Description

Time Frame

Up to approximately six years

Secondary Outcome Measure Information:

Title

Objective Response

Description

From randomisation to occurrence of objective response( complete regression (CR) and partial regression (PR) need to be confirmed 28 days after the occurrence)

Time Frame

Up to approximately six years

Title

Overall Survival, OS

Description

From randomisation to the time of death of any cause.

Time Frame

Up to approximately six years

Title

Clinical benefit Rate

Description

From randomisation to confirmation of objective response

Time Frame

Up to approximately six years

Title

Quality of Life

Description

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)

Time Frame

Up to approximately six months

Title

Adverse Events

Description

From randomisation to the end of follow-up

Time Frame

Up to approximately six years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; Definite history of allergy or allergic constitutions; Chemotherapy, radiotherapy or immunotherapy within four weeks; Administration of other investigational drugs or procedures within four weeks.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lan Bai, Mastor

Phone

+86 18621696315

bailan@hisunbio.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ke Wang, Bachelor

Phone

+86 13761172785

wangke@immunol.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xuetao Cao, M.D.,Ph.D.

Organizational Affiliation

Second Military Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tao Wan, Ph.D.

Organizational Affiliation

Second Military Medical University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yuankai Shi, M.D.,Ph.D.

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Trial of Antigen Pulsed Dendritic Cells (APDC) in Metastatic Colorectal Cancer

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