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Clinical study on the efficacy and safety of HAIC/PD-1 inhibitor combined with lenvatinib in the treatment of unresectable primary liver cancer

Clinical study on the efficacy and safety of HAIC/PD-1 inhibitor combined with lenvatinib in the treatment of unresectable primary liver cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035078
Enrollment
Unknown
Registered
2020-07-30
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

Primary liver cancer

Interventions

Group 1:HAIC+lenvatinib

Sponsors

Affiliated Tumor Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years, regardless of gender 2. Patients with Barcelona clinical liver cancer (BCLC) were classified as stage B or stage C and were unresectable primary liver cancer; 3. Patients with child Pugh A / B liver function; 4. Patients with ECoG score of 0 or 1; 5. Patients with primary liver cancer confirmed by histopathology or clinic.

Exclusion criteria

Exclusion criteria: 1. Patients who have received any systemic chemotherapy or molecular targeted therapy for HCC, such as sorafenib; 2. Patients with any contraindications to TACE, rivatinib, oxaliplatin, calcium folinate or fluorouracil; 3. Patients with poor compliance can not follow the treatment process and follow-up; 4. Patients with severe heart, brain or kidney diseases; 5. Patients with history of organ transplantation; 6. Patients with known history of HIV infection; 7. Patients who had any life-threatening bleeding events within 30 days before enrollment, including transfusion therapy, surgery or local treatment, and continuous drug treatment; 8. Patients with uncontrolled or refractory ascites, persistent variceal bleeding or hepatic encephalopathy; 9. Patients with known central nervous system tumors, including metastatic brain diseases; 10. Patients who are known or suspected to be allergic to the study drug or any drug related to this trial; 11. Pregnant or lactating patients. A fertile woman must have a negative pregnancy test within 7 days before starting the drug study. Male and female participants in this trial must take adequate barrier contraceptive measures during the trial.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall survival;Adverse reactions;

Countries

China

Contacts

Public ContactFeixiang Wu

Cancer Hospital Affiliated to Guangxi Medical University

wufx2013@163.com+86 13707873326

Outcome results

None listed

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