Concurrent Nivolumab and External Beam Radiation Therapy for Patients With Advanced HCC

Advanced Hepatocellular Carcinoma Clinical Trial

— Nextrah  

Official title:

A Phase II Study of Concurrent Nivolumab and External Beam Radiation Therapy for Patients With Advanced Hepatocellular Carcinoma Who Have Vascular Invasion With or Without Sorafenib-Experience in an HBV-endemic Area

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04611165
• Other study ID #: NCC2019-0274
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: November 15, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: October 2020
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy and safety of nivolumab for patients with advanced HCC undergoing EBRT

Description:

Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. External beam radiotherapy begins 2-7 days after the first dose of nivolumab. The study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent or study closure.

After the treatment phase, subjects will undergo follow up for survival every 12 weeks (± 7 days) from the last dose or the use of other anticancer treatments and/or therapies, and the survival follow up will be performed for at least 18 months after the enrollment of the last subject. The patient will be followed for survival follow up and the use of other anticancer treatments and/or therapies.

Based on the assumed dropout rate of 12%, a total of 50 subjects need to perform the study (50=44/(1-0.12))

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with HCC meeting all of following criteria;

1. Signed written informed consent

2. Age >= 20

3. Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center17

4. Having at least one typical enhanced measurable index lesion (in the liver) by dynamic CT or dynamic contrast-enhanced MRI

5. Presence of major vascular invasion on dynamic CT or dynamic MRI

? an intraluminal filling defect adjacent to the primary tumor in portal vein, hepatic vein, and/or inferior vena cava

? an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases.

6. Sorafenib naïve or sorafenib experienced

7. Child-Pugh class A

8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

9. Life expectancy of at least 16 weeks

10. Adequate hematologic and hepatic function (should be obtained within 14 days prior to screening:

• Hemoglobin = 9.0 g/dL

• Absolute neutrophil count (ANC) = 1,000/mm3 ? Platelet count = 50,000/µL

• Total bilirubin < 2.5 mg/dL

• Serum albumin >2.8 g/dL ? Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 × upper limit of normal (ULN) ? Prothrombin time in INR = 1.8 × ULN ? Serum creatinine = 1.5 mg/dL

11. Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 5 months (women) and 7 months (men) after the last study drug administration.

Exclusion Criteria:

• Patients with HCC meeting all of following criteria;

1. Receipt of 2 or more prior systemic therapies for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.

2. Any type of anticancer agent (including investigational) within 2 weeks before enrollment

3. Having active brain metastasis or leptomeningeal metastasis

4. Moderate to severe or intractable ascites

5. A history or presence of hepatic encephalopathy

6. Presence of active bacterial infection

7. Untreated active chronic hepatitis B

8. History of portal hypertension with bleeding within the past 6 months

9. Prior liver transplant

10. Uncontrolled severe medical comorbidity

11. Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years)

12. Current or past history of hypersensitivity to nivolumab

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Nivolumab
Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. EBRT begins 2-7 days after the first dose of nivolumab. The follow-up phase begins when the decision to discontinue study is made. The follow-up phase is defined as the day after the end of study treatment until the day the subject dies.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	Progression-free survival (PFS) is defined as the time from the date of treatment initiation to the date of the first observation of progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1) or death from any cause.	through study completion, an average of 2.5 year.