Phase II/III Study of Radiofrequency Ablation Combined with Cytokine-Induced Killer Cells Treating Colorectal Liver Metastases

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Summary

This clinical trials goal is to determine the safety and efficacy of the combination of radio frequency ablation (RFA) with cytokine-induced killer (CIK) for patients with colorectal liver metastases (CRLMs). The findings suggest that the combination shows to be an efficacious and safe treatment.

Patients characteristics

60 patients age ranging from 18 to 75 years old with a diagnosis of histologically proved colorectal adenocarcinoma, had having complete resection of primary lesions in color or rectum, existence of liver metastases resectable or accessible for radiofrequency ablation (5 or less lung metastatic lesions with the size no larger than 5 cm), ECOG performance status (PS) of 0 or 1 and expected survival of 1 year or longer. The patients must not have extrahepatic metastatic lesions or other neoplastic diseases other than colorectal cancer.
According to receiving CIK cell therapy or not, the patients were divided into Group A (RFA alone) and Group B (RFA plus CIK therapy).

Treatment

Radiofrequency Ablation (FRA)
For all the patients in both Group A and Group B, RFA was performed percutaneously under computed tomography (CT)/ultrasound guidance. All the operations were performed using the RITA 1500 generator composed of a generator that provided 150 W of power and a multitined expandable electrode consisting of a 15-gauge insulated cannula and 9 individual electrodes tines of 10 to 15 cm in length. Each operation of RFA energy maintained 15-25 minutes to from an ablation zone of about 5.0 cm in diameter. If tumors were larger than 3.0 cm, multiple overlapping ablation zones were necessary for tumor destruction and a surrounding rim of non-tumor liver tissue. If patients had more than 1 lesion, each tumor was ablated separately.
CIK cell therapy
All patients in Group B received CIK cell therapy. Seven days before RFA, peripheral blood mononuclear cells (PBMCs) were collected. Seven days after RFA more than 1×109 autologous CIK cells were transfused into the patient via superficial vein within 1 hour. Five transfusions were defined as 1 cycle. The first transfusion in the first cycle was given on day 7 following RFA and each of the 5 transfusions in 1 cycle were performed once every 2 days, which means the 5 transfusions were administered on day 7, 9, 11, 13 and 15, respectively.

Results

PFS and OS
The median PFS times of Group A and Group B were 18.5 months and 23 months, respectively. The 3-year progression-free rates were 13.3% in Group A and 20.3% in Group B, respectively. By the end of follow- up, 9 patients in Group A and 6 patients in Group B had died. The median OS time was 43 months in GroupA, and not reached in Group B. The 3-year OS rates were 64.6% in Group A and 81.0% in Group B, respectively.
Treatment-related AEs
Generally, there were no severe AEs during the treatment. Only 2 patients in Group B had transient low fever and both recovered after symptomatic management. There was no AE in Group A.

Conclusion

This data confirmed that CIK cell therapy can boost the tumor antigen- specific response induced after RFA and the combination of RFA and CIK cell therapy is an efficacious and safe treatment modality for patients with CRLMs.

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Scientific article publishing date 9/30/2016

Immucura identifier BSC21_245EN

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