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TACE and Lenvatinib Plus PD-1 Antibody Versus TACE Plus Lenvtinib for Advanced HCC: a Single-Centre Randomised Controlled Trial

TACE and Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Inhibitor Versus TACE Plus Lenvtinib for Advanced Unresectable Hepatocellular Carcinoma: a Single-Centre Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033668
Enrollment
Unknown
Registered
2020-06-08
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Advanced unresectable HCC

Interventions

Group 1:TACE+Lenvatinib plus toripalimab, an inhibitor of PD1
Group:TACE+Lenvatinib

Sponsors

Eastern Hepatobiliary Surgery Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with clinically or pathologically proven HCC; 2. Patients with at least one measurable lesion; 3. The ECOG physical strength score of patients aged 18-75 years was 0-2; 4. Patients with liver function grade of child Pugh 1.5 * 10^9 / L, platelet > 75 * 10^9 / L; 6. Adequate renal reserve: creatinine = 3 months; 8. Patients who signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Accompanying with PVTT(vp4) and/or ICVTT; 2. Pd-1 inhibitors have been used in the past; 3. Previous history of other systemic tumors, except: (1) carcinoma in situ; (2) treated basal cell carcinoma; (3) superficial bladder cancer (ta,tis and T1); (4) any cancer 4 that received radical treatment three years ago; 4. Severe heart, brain, lung, kidney and blood system diseases; 5. The presence of brain or meningeal metastasis; 6. The time of venous thrombosis, such as cerebral vascular accident, deep venous thrombosis and pulmonary embolism, occurred within 6 months before admission to the group; 7. Pregnant or lactating women; 8. Participants in other clinical trials; 9. Have a history of allogeneic organ transplantation; 10. Known or suspected history of allergy to biological agents, anaphylaxis or being in anaphylaxis; 11. 4 weeks before treatment, bleeding occurred at any part of >= CTCAE3 grade, with unhealed wounds, ulcers or fractures; 12. Unhandled intestinal obstruction that could not be feeded or administrated systemically; 13. HIV infection or aids-related diseases; 14. Inflammatory infections scheduled for active infection; 15. According to the researchers, patients with concomitant diseases that are likely to seriously endanger their own safety or may affect the completion of the study; 16. Having a history of mental illness or behavioral abnormalities; 17. with heart failure, chest pain (medically uncontrollable), myocardial infarction within 12 months before the start of the study; 18. the researchers determined that they were not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
ORR;DOR;PFS;DCR;clinical benefit rate;

Countries

China

Contacts

Public ContactWu Dong

Oriental Hepatobiliary Surgery Hospital

WuDongEHBH@126.com+86 13072188118

Outcome results

None listed

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