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

NCT02503150 | Unknown Phase 3 DMC

• 1 other identifier: SMMU, Shanghai
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal Cancer; Tumor Therapeutic Vaccine; Dendritic Cell

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Objective Response

  Up to approximately six years

• Overall Survival, OS

  Up to approximately six years

• Clinical benefit Rate

  Up to approximately six years

• Quality of Life

  Up to approximately six months

• Adverse Events

  Up to approximately six years

Study Arms (2)

APDC + Chemotherapy

EXPERIMENTAL

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

Biological: APDC + Chemotherapy

Chemotherapy

ACTIVE COMPARATOR

Patients in Arm Chemotherapy will receive chemotherapy only.

Drug: Chemotherapy

Interventions

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).

APDC + Chemotherapy

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).

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Military Medical University: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Changhai Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Fudan University: collaborator
• Shanghai Changzheng Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• RenJi Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• First People's Hospital of Hangzhou: collaborator
• 307 Hospital of PLA: collaborator
• Huashan Hospital: collaborator
• Ruijin Hospital: collaborator
• Shanghai Haixin Biotechnology Co. Ltd: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Bai, Mastor

CONTACT

+86 18621696315; bailan@hisunbio.com

Ke Wang, Bachelor

CONTACT

+86 13761172785; wangke@immunol.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: July 30, 2015

Record last verified: 2015-07