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PD-1 in HCC Phase I/II (IIT)

Background

Liver cancer is a malignant tumor that occurs in the liver or initiates from the liver. The primary liver cancer, also known as malignant liver tumors or hepatocellular carcinoma is originated from the abnormal cell division of hepatocytes.
It is the third most common cause of cancer-related deaths.
Symptoms of liver cancer include lumps or pain under the right side of the rib cage, ascites, jaundice, easy bruising, weight loss, and physical weakness.

Cirrhosis is mainly developed from Hepatitis B, Hepatitis C or long-term heavy intake of alcohol and it is a main cause of liver cancer. Other causes related to liver cancer include aflatoxin, non-alcoholic fatty liver disease and clonorchis sinensis. The most common type is hepatocellular carcinoma, accounting for 80%.

Prophylactic measures include Hepatitis B vaccine and treatment of patients already suffering from Hepatitis B or C to avoid the progression to liver cancer. Screening and treatment of chronic liver disease are recommended to diseased patients. Liver cancer can be diagnosed by blood tests and medical imaging, and further confirmed by biopsy. Treatments include surgery, target therapies and radiotherapy, as well as radiofrequency ablation (RFA), embolization or liver transplantation under certain conditions.

Unmet Medical Needs

Rising of cancer incidence is a growing problem worldwide. Liver cancer is the first cause of cancer-related of men deaths in Taiwan. Because of disease diversity and high recurrence rate, there are several kinds of treatments had been developed. Surgical resection is a typical method for curative treatment for the early stage HCC. However, high incidence of recurrence of HCC is commonly happened with surgical resection, which leads to a poor prognosis. Multiple factors can contribute to the recurrence. Liver resection in patients with underlying cirrhosis is associated with a significant risk of recurrence or postoperative morbidity and/or mortality.

There is no standard medical management method to decrease the reoccurrence rate after liver resection. To develop preventive treatments for decreasing liver cancer recurrence rate from the prevention medicine point of view may avoid liver cancer recurrence again, and further decrease the mortality rate caused by liver cancer.

Incentive of The Trial

Among patients with hepatitis B-induced hepatocellular carcinoma, the recurrence rate after 3 years is about 40% and 60% within 5 years after curative surgery. However, there are no conventional therapy, or other alternative therapies at current stage to decrease recurrence rate after resection. Patients can only be tracked regularly, therefore it is necessary for the novel and effective treatment.

This trial is an exploratory study to evaluate safety and the prophylactic effect of anti-PD1 monotherapy, P1101 monotherapy, and sequential administration of P1101 and anti-PD1 in subjects received curative surgery of hepatitis B-related HCC, with reduction of recurrence rate.