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PD-1 antibody combined with different doses of stereotactic body radiation therapy for advanced hepatocellular carcinoma: a randomised pilot trial (SBRT+PD-1 GXHCC-002)

PD-1 antibody combined with different doses of stereotactic body radiation therapy for advanced hepatocellular carcinoma: a randomised pilot trial (SBRT+PD-1 GXHCC-002)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032375
Enrollment
Unknown
Registered
2020-04-27
Start date
2020-04-25
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

hepatocellular carcinoma

Interventions

Three groups:30Gy/10 fractions vs 40Gy/10 vs 50Gy/10 fractions

Sponsors

Guangxi Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-70 years; 2. Histologically diagnosed hepatocellular carcinoma, or that meets the criteria of the American association for the study of hepatology for the clinical diagnosis of hepatocellular carcinoma; 3. Liver function child-pugh grade A; 4. ECOG 0-1; 5. Expected survival of > for 3 months; 6. Hemoglobin >=90g/L; Neutrophil absolute count (ANC) >=1.5x10^9/L; Platelet >60x10^9/L; ALT, AST 3 ULN or less; Serum total bilirubin =30g/L; 7. Unwilling to accept or unable to tolerate first-line sorafenib or lenvastinib treatment; 8. The patient and its authorized legal representative understand and agree to sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) previous or co-existing malignancy, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; (2) previously received anti-pd-1 drugs or drugs that stimulate or synergistically inhibit T cell receptor; (3) received radiotherapy within 6 months before administration; (4) an active autoimmune disease requiring systemic treatment occurred in the 2 years prior to enrollment; (5) known severe allergic reaction to pd-1 monoclonal antibody; (6) an active infection requiring systemic treatment; (7) patients with a clear tendency to gastrointestinal bleeding; (8) hyperarteriovenous/venous thrombotic events occurred within one year; (9) persons with a history of substance abuse and unable to quit or mental disorders.

Design outcomes

Primary

MeasureTime frame
PFS;Side effects;

Secondary

MeasureTime frame
Objective response rate;Overall survival;

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 13, 2026