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Endorstar, IL-2 arterial infusion with hepatic arterial infusion chemotherapy and camrilizumab for unresectable hepatocellular carcinoma

Endorstar, IL-2 arterial infusion with hepatic arterial infusion chemotherapy and camrilizumab for unresectable hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047911
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

hepatocellular carcinoma

Interventions

case series:Endotherapy + IL-2 + HAIC combined with carrilimab

Sponsors

Shaanxi Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients voluntarily joined the study and signed the informed consent; 2. Aged >= 18 years; 3. Pathologically diagnosed advanced hepatocellular carcinoma, who have not received any treatment, or have failed previous first-line treatment, including failure of sorafenib or lenvatinib treatment or hepatic arterial infusion chemotherapy, failure of TACE treatment (disease progression or intolerable toxicity), failure of immunotherapy; 4. Child-Pugh score = 12 weeks; 9. The function of vital organs meets the following requirements (the use of any blood components, cell growth factors and other drugs for corrective treatment is not allowed within 14 days before the first dose): (1) Absolute neutrophil count >=1.5x10^9/L; platelets >=80x10^9/L; hemoglobin >=90 g/L; serum albumin >=28 g/L; (2) Thyroid-stimulating hormone (TSH) <= 1xULN (if abnormal, the levels of FT3 and FT4 should be investigated at the same time, if the levels of FT3 and FT4 are normal, they can be included in the group); (3) Bilirubin<=1.5xULN (within 7 days before the first administration); ALT and AST<=3xULN (within 7 days before the first administration); AKP<=2.5xULN; serum creatinine<=1.5xULN; 10. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; Non-surgical sterilized female patients of childbearing age must have a negative serum or urine HCG test within 72 hours before study enrollment; and must be non-lactating; For male patients whose partners are women of childbearing potential, effective contraception should be used during the trial and for 3 months after the last dose of camrelizumab.

Exclusion criteria

Exclusion criteria: 1. Combined with severe heart, brain, lung, kidney and other important organ dysfunction, combined with severe infection or other serious concomitant diseases (>2 grade CTCAE Version 5.0 adverse events), those who cannot tolerate treatment; 2. Those with a history of other malignant tumors; 3. Those with a history of related drug allergies; 4. Those with a history of organ transplantation; 5. Patients with HIV infection; 6. There are drug addicts or drug abusers; 7. Those who have experienced gastrointestinal bleeding or cardiovascular and cerebrovascular events within the past 30 days of treatment; 8. Combined with mentally ill persons who are unable to give informed consent or affect the treatment; 9. Other factors that may affect patient enrollment and evaluation results.

Design outcomes

Primary

MeasureTime frame
Overall response rate;

Countries

China

Contacts

Public ContactLi Zhubin

Shaanxi Provincial Cancer Hospital

xihuan-aa@163.com+86 13759887494

Outcome results

None listed

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