Skip to content

TACE plus radiotherapy downstaging to surgery vs. surgery alone for primary resectable HCC lesions with type II-III portal venous thromboembolism (PVTT): A prospective, randomized controlled, phase III clinical study (GX-HCC-003)

TACE plus radiotherapy downstaging to surgery vs. surgery alone for primary resectable HCC lesions with type II-III portal venous thromboembolism (PVTT): A prospective, randomized controlled, phase III clinical study (GX-HCC-003)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036072
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-08-20
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

hepatocellular carcinoma

Interventions

Sponsors

Guangxi Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years old; 2. Primary resectable liver cancer patients combined with TYPE II-III PVTT (in line with EASL liver cancer diagnostic criteria in 2018); 3. Child-pugh level A in liver function; 4. ECOG PS 0; 5. Expected survival time more than 3 months; 6. ALT and AST no more than 3 ULN, platelet >=80x10~9 /L, creatinine less than 150 umol/L; 7. The patient and his/her authorized legal representative understand and agree to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Previous history of upper abdominal radiation therapy; 2) Child-pugh grade B or above in liver function; 3) Extrahepatic or regional lymph node metastasis; 4) There is contraindication to radiotherapy or TACE; 5) History of severe esophageal varices combined with bleeding or active gastrointestinal bleeding within 2 weeks of enrollment; 6) Pregnant or breastfeeding; 7) Had been treated with systemic chemotherapy, targeted or immunosuppressive drugs in the past 6 months; 8) Tumor rupture and hemorrhage.

Design outcomes

Primary

MeasureTime frame
OS;Cancer thrombotic downstaging rate;complications;

Secondary

MeasureTime frame
PFS;R0 resection rate;

Countries

China

Contacts

Public ContactTING-SHI SU

Guangxi Medical University Cancer Hospital

sutingshi@163.com+86 18878708186

Outcome results

None listed

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