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Efficacy and safety of stereotactic radiotherapy combined with Sindilizumab and bevacizumab in the treatment of hepatoma with portal vein cancer thrombus: an open, one-arm exploratory study

Efficacy and safety of stereotactic radiotherapy combined with Sindilizumab and bevacizumab in the treatment of hepatoma with portal vein cancer thrombus: an open, one-arm exploratory study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072239
Enrollment
Unknown
Registered
2023-06-07
Start date
2022-11-24
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Primary liver cancer

Interventions

Treatment group:Stereotactic radiotherapy combined with sindilizumab and bevacizumab

Sponsors

Eastern Hepatobiliary Surgery Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Men or non-pregnant women aged between 18 and 70; 2. Sign informed consent; 3. The investigator believed that the patients were capable of complying with the study protocol; 4. Hepatocellular carcinoma (HCC) was diagnosed histologically or cytologically or clinically. Patients with cirrhosis were diagnosed clinically using AASLD criteria, while patients without cirrhosis were diagnosed histologically. 5. Imaging examination confirmed the presence of portal vein cancer thrombus; 6. The disease is not suitable for radical surgery; 7. Has not received any antitumor therapy in the past; 8. At least 1 measurable (measurable according to RECIST1.1) untreated lesion.

Exclusion criteria

Exclusion criteria: 1) Local treatment (including radiofrequency ablation and external radiotherapy) was performed before enrollment. 2) The tumor has developed distant metastasis, such as metastasis of lung, brain, bone, etc 3) Imaging suggested the formation of hepatic vein and vena cava cancer thrombus. 4) Severe varicose esophagus and gastric fundus veins, prone to gastrointestinal bleeding, or previous history of massive gastrointestinal bleeding; 5) Patients with heart, lung and renal insufficiency. Oral administration of warfarin and other anticoagulant drugs within 2 weeks. 6) Researchers believe that participants should not participate in this study for other reasons.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Secondary

MeasureTime frame
Adverse reactions and complications;Overall survival time;disease control rate;progression-free survival time;surgical resection rate;

Countries

China

Contacts

Public Contactshuqun Cheng

Eastern Hepatobiliary Surgery Hospital

chengshuqun@aliyun.com+86 21 8188 7581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026