Combined Immunotherapy and Targeted Therapy for Advanced Liver Cancer
Status:
Unknown status
Trial end date:
2020-11-30
Target enrollment:
Participant gender:
Summary
Liver cancer is a common malignant tumor in China, and its incidence rate ranks third and
remains high. The treatment of liver cancer has made some progress in recent years, mainly
the progress of radical treatment such as surgery and ablation. For liver cancer, due to the
emergence of molecularly targeted drugs such as sorafenib and immunological checkpoint
inhibitors, the systemic therapeutic effect of advanced liver cancer is improved, and the
curative effect is further improved. In recent years, immunotherapy has become one of the
clinical treatment options for cancer. T lymphocytes are a cell with cell killing ability in
the immune system, and programmed death factor 1 (PD-1) is an important inhibitory receptor
on the surface of T lymphocytes. It is known that the ligands of PD-1 are PD-L1 and PD-L2,
and studies have found that a variety of tumor cells have high expression of PD-L1 ligand on
the surface. At present, clinical research on target drugs for PD-1 has included dozens of
solid tumors or hematological tumors. The results of clinical studies that have been
completed and the interim results of some studies indicate that anti- PD-1 antibody drugs are
more effective and safer than previous treatments. Patients with hepatocellular carcinoma
(HCC) often undergo liver cancer resection, but the recurrence rate can reach 70% to 100%,
which seriously affects the treatment outcome and long-term survival rate. Early recurrence
of liver cancer is mainly related to the invasiveness of the tumor. Microvascular invasion,
non-anatomical hepatectomy, AFP greater than 32 ng/ml, tumor diameter greater than 5 cm, and
incomplete tumor capsule are risk factors for recurrence within 2 years after surgery. Hence,
it is necessary to determine the risk factors for HCC recurrence and the markers for
continuous monitoring of anti-tumor response before and after surgery. Circulating tumor
cells (CTCs) is an integral part of "liquid biopsy" and has great potential to change the
current treatment modality in the cancer field. CTCs are derived from solid tumors and are
associated with hematogenous metastasis. Therefore, analyzing the level of CTC has clinical
guiding significance. For liver cancer patients, overall survival (OS) tended to be poorer in
patients with CTCs. Although surgical treatment of liver cancer has benefited most patients
with liver cancer, monitoring postoperative recurrence, further improving the long-term
prognosis of liver cancer, postoperative detection of CTCs and other related indicators,
combined with targeted, immune and other related treatments for further study. It is expected
to receive 100 patients (50 treatment groups, 50 control groups). Patients who underwent
immunotherapy after surgery were assigned to the immunotherapy group, and patients who were
not treated with sorafenib after surgery were classified as the control group. All patients
underwent 7 CTCs tests (immunomagnetic beads negative enrichment-targeted PCR) before, 7 days
after surgery and 1st, 3rd, 6th, 9th, and 12th postoperatively. All patients were observed
from the observation period. After the liver cancer resection, the patient was observed to
have died, lost to follow-up or the end of the study.