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Neoadjuvant PD-1 plus Radiotherapy in Patients with Locally Advanced Hepatocellular Carcinoma: a Single Arm Study

Neoadjuvant PD-1 plus Radiotherapy in Patients with Locally Advanced Hepatocellular Carcinoma: a Single Arm Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036385
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

experimental group:PD-1 monoclonal antibody combined with radiotherapy followed by radical liver resection

Sponsors

Third Affiliated Hospital of the Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Between 18-70 years old, ECOG PS score 0/1; 2) Clinical confirmed hepatocellular carcinoma; 3) Locally advanced HCC (BCLC stage C without extrahepatic metastasis), potentially resectable; 4) At least one measurable target lesion (according to RECIST 1.1); 5) Have not received any other treatment against HCC previously; 6) Child-Pugh A/B; 7) The predicted life expectancy equals or is longer than 6 months; 8) Agreed to purchase and receive Tislelizumab treatment after surgery; 9) Know the research process and agree to participate, sign relevant informed consent and other documents.

Exclusion criteria

Exclusion criteria: 1) Allergic to PD-1/PD-L1 antibody or radiotherapy; 2) Have been treated with PD-1/PD-L1 or PD-L2 antibody, other stimulatory or co-inhibitory T cell receptor agents (such as CTLA-4OX-40 or CD137 antibody), or have participated in other similar clinical trials; 3) Have a history of other tumors other than HCC in the past 5 years; 4) Pregnant or lactating women; 5) Have a history of interstitial lung disease, non-infectious pneumonia or other uncontrolled systematic disease including diabetes, hypertension, pulmonary fibrosis or acute respiratory diseases; 6) Have a history of severe cardiovascular disease in the past 12 months; 7) Have current immunodeficiency or autoimmune diseases or a history of any immunodeficiency or autoimmune diseases; 8) Have a history of allogenic transplantation; 9) Have received steroids treatment of other systematic immunosuppressive therapy 14 days before enrollment; 10) Have other uncured malignant tumors; 11) Patients with immunodeficiency, such as HIV positive patients; 12) Have uncontrolled mental diseases.

Design outcomes

Primary

MeasureTime frame
Objective response rate;Overall survival;

Secondary

MeasureTime frame
Pathological response rate;Recurrence-free survival;Safety;

Countries

China

Contacts

Public ContactRuoyu Wang

Third Affiliated Hospital of the Naval Medical University

ffsmmu_wang@126.com+86 158 0079 1175

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026