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Study of lenvatinib combined with iNKT cell immunotherapy for advanced hepatocellular carcinoma

Study of lenvatinib combined with iNKT cell immunotherapy for advanced hepatocellular carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059194
Enrollment
Unknown
Registered
2022-04-26
Start date
2022-01-05
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

hepatocellular carcinoma (HCC)

Interventions

Experimental group:iNKT cells infusion combined with lenvatinib

Sponsors

Beijing You'an Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, no gender limit. 2. All the cases were hepatocellular carcinoma clinically or pathologically confirmed by CT, nuclear magnetic imaging, etc., with stage C BCLC, initial treatment or progress since the last anti-tumor therapy. 3. Expected survival >12 weeks. 4. Other indicators: white blood cell count >=3x10^9/L; Absolute lymphocyte count >=0.8x10^9/L; Hemoglobin >=85 g/L; Platelet count >=50x10^9/L; Serum creatinine < 1.5x upper limit of normal. 5. At least 10 iNKT cells /ml were detected by flow cytometry in patients' peripheral blood. 6. Understand and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Uncontrollable systemic diseases such as hypertension, heart disease history, etc. 2. The presence of portal vein main cancer thrombus, central nervous system tumor metastasis or other tumors. 3. Within 4 weeks before the study (blood collection), radiotherapy and chemotherapy for the disease under study, local therapy, and targeted antitumor drugs were used. 4. With unstable immune system or infectious disease. 5. Infected with syphilis and HIV. 6. Patients with a history of stem cell transplantation or organ transplantation. 7. Allergic to immunotherapy and related drugs. 8. There are liver disease related complications requiring treatment: moderate or severe pleural effusion, pericardial effusion, ascites, upper gastrointestinal bleeding. 9. Pregnant and lactating patients. 10. The clinician considers it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Disease Control Rate (DCR);Progression-Free Survival(PFS);Safety;

Secondary

MeasureTime frame
Inkt-related Immune Response Indicators;Alpha-fetoprotein;

Countries

China

Contacts

Public ContactXiong Fang

Beijing You'an Hospital, Capital Medical University

xiongf2010@126.com+86 10 83997153

Outcome results

None listed

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