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An exploratory study comparing the efficacy and safety of alpha-interferon combined with anti-PD-1 monoclonal antibody as an adjuvant therapy in HCC patients with portal vein tumor thrombus after hepatectomy

An exploratory study comparing the efficacy and safety of alpha-interferon combined with anti-PD-1 monoclonal antibody as an adjuvant therapy in HCC patients with portal vein tumor thrombus after hepatectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037461
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

Hepatocellular carcinoma

Interventions

Therapy Group:interferon a+ anti-PD-1
Control Group:no intervention

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-75 years; 2. diagnosed with portal vein tumor thrombus and no evidence for new PVTT after surgery; 3. CT 4 weeks after surgery showed no evidence of tumor; 4. ECOG score 0-1; 5. Child-Pugh score A(5-6); 6. AFP lower than 400ng/mL; 7. patients with chronic hepatitis B: under anti-HBV therapy at least 4 weeks, and HBV virus load less than 500IU/mL; 8. recovered from surgical complications; 9. signed Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. history of other cancers; 2. serious concomitant disease; 3. portal hypertension; 4. uncontrolled ascites or hepatic encephalopathy; 5. HIV infection; 6. pregnant or lactating; 7. previously have non-infective pneumonia and treated with steroids, or have pneumonia at present; 8. systemic infection; 9. injected with vaccine within 1 month.

Design outcomes

Primary

MeasureTime frame
RFS;OS;—

Countries

China

Contacts

Public ContactLu Wang

Fudan University Shanghai Cancer Center

wanglushanghaicancercenter@hotmail.com+86 13601678615

Outcome results

None listed

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