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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Military Medical University
• Collaborators: 307 Hospital of PLA; Beijing Cancer Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Changhai Hospital; Chinese PLA General Hospital; First People's Hospital of Hangzhou; Fudan University; Huashan Hospital; RenJi Hospital; Ruijin Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shanghai Changzheng Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Haixin Biotechnology Co. Ltd; The 307th Hospital of Chinese People`s Liberation Army; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Zhejiang Cancer Hospital

Criteria

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the colorectum with metastatic lesions and received no previous therapy for metastatic lesions;

2. Be able to undergo surgical resection to obtain at least 1cm3 tumor tissues;

3. The patients are from 18-75 years old regardless of gender;

4. An estimated life expectancy of more than 6 months with ECOG≤2;

5. 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;

6. 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);

7. Written informed consent.

Exclusion Criteria:

1. 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;

2. Metastases lesions> 50% of liver volume;

3. Autoimmune diseases, organ transplantation requiring immunosuppressive therapy and patients requiring long-term systemic corticosteroid therapy;

4. History of other malignant diseases (except cured basal cell carcinoma and cervical carcinoma in situ) in the last 5 years;

5. 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);

6. Acute or chronic infectious diseases in active phase; severe uncontrolled infection, or other serious uncontrolled concomitant diseases;

7. Definite history of allergy or allergic constitutions;

8. Chemotherapy, radiotherapy or immunotherapy within four weeks;

9. Administration of other investigational drugs or procedures within four weeks.