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Study on the effect of adjuvant PD-1 monoclonal antibody in patients with hepatocellular carcinoma complicated with microvascular tumor thrombus

Study on the effect of adjuvant PD-1 monoclonal antibody in patients with hepatocellular carcinoma complicated with microvascular tumor thrombus

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037655
Enrollment
Unknown
Registered
2020-08-16
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

HCC combined with microvascular tumor thrombus

Interventions

experimental group :anti-PD-1 200mg Q3W,6mongths

Sponsors

The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 20 to 70 years old with liver cancer complicated with mivi (stage I) can receive surgical treatment; 2. Two senior liver surgeons considered that the tumor was resectable, and there were no extrahepatic metastasis and adjacent organ invasion before operation; 3. Patients with ehbh-mvi score > 4; 4. For patients with ECoG score of 0-1, child grade A or grade B of liver function in screening period was 7 points; 5. Patients with HCC confirmed by pathology; 6. Patients without significant heart, lung and kidney dysfunction were not infected with HCV, HIV or syphilis; 7. All patients should sign informed consent when they are selected.

Exclusion criteria

Exclusion criteria: 1. Patients with intrahepatic or extrahepatic recurrence within 1 month after operation; 2. Patients with intolerable side effects or clinical accidents after the first treatment with sindilimab; 3. Patients with unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction in the past 6 months and QT interval prolongation (> 450ms); 4. Patients with other malignant tumors in the last 5 years; 5. Patients can not accept follow-up or are participating in other clinical trials; 6. Pregnant women.

Design outcomes

Primary

MeasureTime frame
RFS;

Secondary

MeasureTime frame
OS;PFS;Change of AFP;

Countries

China

Contacts

Public ContactKang Wang, Shuqun Cheng

The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army

wangkang_md@aliyun.com+86 18817302388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026