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Advanced primary hepatocellular carcinoma treated by radiotherapy combined with tislelizumab: a single arm, single center clinical study

Advanced primary hepatocellular carcinoma treated by radiotherapy combined with tislelizumab: a single arm, single center clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039022
Enrollment
Unknown
Registered
2020-10-13
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

primary hepatocellular carcinoma

Interventions

single group:radiotherapy combined with tislelizumab

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) locally advanced metastatic or unresectable hepatocellular carcinoma (or both); (2) Had not received systemic/systemic treatment before, and was allowed to receive antiviral treatment at the same time; (3) At least one measurable lesion; (4) It is not suitable for regional treatment (TACE and RFA) or has progressed after treatment; (5) ECOG PS score 0-1; (6) Child-pugh level A in liver function; (7) Adequate blood function (platelet count >= 60 x 10^9/L;Hemoglobin >= 85g/L;International standard ratio of prothrombin time (INR) = 28g/L;Total bilirubin 3 months; (11) Men and women, aged 18 or above; (12) No history of liver radiotherapy and no severe cirrhosis; (13) No history of severe allergy; (14) Accept radiotherapy voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Received molecular targeted therapy, anti-angiogenesis therapy or other systemic therapy in recent 3 months. (2) There is a risk of bleeding or bleeding from autoimmune diseases or untreated diseases of the esophagus, stomach and digestive tract. (3) Other parts, such as the lungs, cardiovascular and cerebrovascular system, gynecology, urinary system, blood system, etc., have higher blood risk. (4) Pregnant or nursing patients. (5) Patients with signs of brain metastasis, hepatic encephalopathy, diseases of the blood system and cardiac insufficiency. (6) Severe complications: extremely high risk hypertension, massive cerebral infarction, massive myocardial infarction, cardiac function >= Grade II, history of mental illness, and severe diabetes. (7) Have a history of severe allergy. (8) Patients with moderate to severe pulmonary dysfunction, silicosis and other pulmonary fibrosis. (9) Patients with moderate to severe hypothyroidism. (10) Patients who could not tolerate the treatment and could not cooperate with the visitors.

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
objective remission rate;

Countries

China

Contacts

Public ContactZhang Jianwen

Affiliated Hospital of Southwest Medical University

zhangjianwen66@126.com+86 13989132187

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026