Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients With Hepatocellular Carcinoma

NCT03857815 | Unknown Phase 2

• 1 other identifier: ZS-HCC-SBRTPD1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy and safety of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival

  2 years

Secondary Outcomes (4)

• Adverse Events

  2 years

• OS

  2 years

• DCR

  2 years

• ORR

  2 years

Study Arms (1)

SBRT in combined with anti-PD-1 antibody

EXPERIMENTAL

HCC Patients will be received stereotactic body radiation therapy (SBRT) to primary lesions or metastatic lesions, such as liver, lung, bone, brain or lymph nodes and concurrent anti-PD-1 antibody treatment.

Radiation: anti-PD-1 antibody

Interventions

anti-PD-1 antibody RADIATION

In patients with inoperable hepatocellular carcinoma or recurrence after local or regional therapy, stereotactic body radiation therapy will be combined with anti-PD-1 antibody. Stereotactic body radiation therapy: SBRT is delivered to 1\~5 Evaluable lesions of liver, lung, bone, brain or lymph nodes in limited fractions . Anti-PD-1 treatment: anti-PD-1 antibody (IBI308) is injected intravenously 200mg every three weeks.

SBRT in combined with anti-PD-1 antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: 18 Years to 75 Years (Adult, Older Adult)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of hepatocellular carcinoma (HCC) based on either histopathologic or cytologic findings or a diagnosis of cirrhosis and HCC with classical imaging characteristics.
• Patients including metastasis are inoperable or unresectable. Prior locoregional therapy including radiofrequency ablation, transarterial chemoembolisation, radioembolisation is allowed provided that radiologically progressive disease is demonstrated following these locoregional therapies. Lesions should be no more than five and be able to administrate SBRT, and at least one lesion is evaluable.
• The Laboratory test results must meet the following criteria:
• neutrophils ≥1.5×109/L
• Platelets ≥75×109/L
• Hemoglobin ≥90g/L (no blood transfusion within past 14 days)
• Serum Cr ≤1.5×ULN, endogenous creatinine clearance rate \>60ml/min (Cockcroft-Gault formula)
• AST ≤2.5×ULN, ALT ≤2.5×ULN; both ALT and AST ≤5×ULN if there are liver metastasis
• TSH, FT3, FT4 are within ± 10% of the normal range
• blood coagulation functon: INR ≤2.5×ULN and APTT ≤ 1.5 ULN
• ECOG performance status: 0-1.
• Life expectancy ≥6 months.
• No history of abdominal irradiation.
• aged 18 to 75 years old are eligible.
• Patients must be able to understand and willing to sign a written informed consent document.

You may not qualify if:

• Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma.
• History of hepatic encephalopathy or liver transplantation
• Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion without symptoms could be included.
• Untreated hepatitis infection: HBV DNA\>2000IU/mlor104 copy/ml, HCV RNA\> 103copy/ml, both HbsAg and anti-HCV body are positive.
• Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of ≤1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of ≤ 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
• In the past six months, there was a history of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive intestinal resection (partial or extensive intestinal resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea.
• History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity;
• Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active tuberculosis infection within 1 year should be excluded even if they have been treated.
• Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
• Severe infections are in active stage or under clinical control. Severe infections occurred within 4 weeks before the first treatment, including but not limited to hospitalization due to infection, bacteremia or complications of severe pneumonia.
• Patients with active, known or suspected autoimmune diseases. Patients with the following conditions can be selected: vitiligo, type I diabetes, residual thyroid dysfunction caused by autoimmune thyroiditis that just need hormone replacement therapy, or diseases that will not relapse without external stimulating factors
• Immunosuppressive drugs have been used in the past four weeks, excluding local glucocorticoids or systemic glucocorticoids (i.e. no more than 10 mg/day prednisone or other glucocorticoids of equivalent dosage) through nasal spray, inhalation or other routes, and temporary use of glucocorticoids for the treatment of dyspnea symptoms of asthma, chronic obstructive pulmonary disease.
• Inoculation of any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within past 4 weeks;
• Received systemic immunostimulant therapy in the past four weeks
• Large surgical (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures have been performed in the past four weeks.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Zhao-Chong Zeng, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Tian-shu Liu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao-Chong Zeng, PhD

CONTACT

86-64041990-2764; zeng.zhaochong@zs-hospital.sh.cn

Yixing Chen, PhD

CONTACT

86-64041990-2764; chen.yixing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 28, 2019
• Study Start: March 25, 2019
• Primary Completion: September 30, 2020
• Study Completion: February 28, 2022
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

CN (1)