Phase IB/II Study of NRT Combined With Radiotherapy for Advanced HCC

Phase 1

• Conditions: HCC
• Interventions: Biological: NRT; Radiation: Radiotherapy

• Registration Number: NCT03199807
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.

Detailed Description

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer-related death worldwide. The resection rate for HCC is approximately 10%-30% and the overall prognosis is very poor with a 5-year survival rate of 5%-6%. The recurrence rate is high after radical resection. In addition to surgery, radiofrequency ablation, transcatheter arterial chemoembolization (TACE), microwave ablation, cryoablation, radioactive seeds implantation, high-intensity-focused ultrasound, radiation therapy, chemotherapy and targeted drugs are available for patients with unresectable tumors; however, the efficacy of these treatments are limited and long-term prognosis in the patients is still poor. Moreover, due to serious side effects induced by treatments such as TACE, chemotherapy and targeted drugs, it may not be possible for patients to continue receiving these therapies. The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-18
• Study First Submitted QC: 2017-06-24
• Last Update Submitted: 2017-06-24
• Study First Posted: 2017-06-27
• Last Update Posted: 2017-06-27
• Study Start: 2017-07-20
• Primary Completion: 2020-07-20
• Study Completion: 2021-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Female or male aged 18 years and over, but no more than 75 years;
2. Histologic or cytologic confirmation of advanced hepatocellular carcinoma;
3. Patients with measurable lesions but can not be treated with surgery;
4. Patients with two or over measurable lesions;
5. ECOG≤0-2, Child-pugh A-B;
6. Patients had not received systemic venous chemotherapy ever before;
7. Hematology Index;
8. Neutrophile granulocyte greater than 1.5×10^9/L;
9. Hemoglobin greater than 10g/dL;
10. Platelet greater than 90×10^9/L;
11. Biochemical index
12. Serum bilirubin not greater than 1.5x upper limit of reference range （ULN）
13. ALT or AST not greater than 1.5x ULN
14. Creatinine clearance no less than 60ml/min;
15. Negative pregnancy test for women of childbearing potential;
16. Provision of informed consent;
17. Be able to follow the research program and follow up process;
18. Expected survival time 3 months or more.

Exclusion Criteria

1. Chemotherapy with experimental drug within 3 months before the start of study therapy;
2. Have at least another primary malignant tumor;
3. Active infection with bacterial or fungal infection;
4. Patients with HIV infection, HCV infection, serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group;
5. Women who are pregnant or breast feeding;
6. Drug abuse, clinical or psychological or social factors which will influence the informed. consent or the study implementation;
7. May be allergic to immunotherapy;
8. Radiotherapy and immunotherapy may not be implemented due to social or geographical factors;
9. Weight loss greater 10% within 6 weeks before the start of study therapy;
10. influence the safety or compliance of the patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NRT + radiotherapy	Radiotherapy	HCC received NRT and radiotherapy
NRT + radiotherapy	NRT	HCC received NRT and radiotherapy

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	up to 6 months	using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients

Secondary Outcome Measures

Name	Time	Method
Response Rate	3, 6 and 12 months	Response Rate（RR） will be evaluated according Response Evaluation Criteria
Progression free survival (PFS)	3, 6, 9 and 12 months	the duration of progression free survival is measured from the time of treatment to the first date that recurrent or progressive disease or for any reason of death is objectively documented
Overall Survival (OS)	At 6, 12 and 18 months	the duration is measured from the time of treatment to the time of death