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A prospective exploratory study on the efficacy and safety of cryoablation combined with regofinib and tirelizumab in the treatment of advanced hepatocellular carcinoma

A prospective exploratory study on the efficacy and safety of cryoablation combined with regofinib and tirelizumab in the treatment of advanced hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063134
Enrollment
Unknown
Registered
2022-08-31
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Hepatocellular carcinoma

Interventions

Advanced liver cancer group:cycoalbation

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Obtain written informed consent; 2. Aged >=18 years; 3. Subjects must have unresectable or metastatic hepatocellular carcinoma (BCLC stage B or BCLC Stage C), histologically or cytologically confirmed; 4. Subjects had progression or intolerance to first-line systemic therapies for advanced hepatocellular carcinoma (systemic chemotherapy (oxaliplatin-based chemotherapy), targeted therapies (such as sorafenib or lenvatinib), or anti-PD-1 or anti-PD-L1 regimens); 5. CT or MR examination showed at least one measurable lesion according to RECIST criteria, and there was one ablable lesion less than 5cm; 6. PS=0~1; 7. Life expectancy of at least 3 months; 8. Blood cell count, liver and kidney function conforming to the standards: Neutrophil count >=1500 /L, platelet >=75 x10^3/L; Total bilirubin =31 g/dL; Serum creatinine =30 mL/min(if using Cockcroft-Gault formula); 9. Child-pugh score <=7 points; 10. Female subjects with reproductive potential must have a negative urine or serum pregnancy test within 7 days before the trial begins; 11. The subject is willing and able to abide by the protocol during the study, including treatment, contraceptive compliance, scheduled visits and examinations, including follow-up.

Exclusion criteria

Exclusion criteria: 1. Clinically significant gastrointestinal bleeding within 4 weeks prior to initiation of treatment. 2. Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, except portal vein segment thrombosis, occurred within 6 months prior to the first dose of the study drug. 3. Prior cryoablation for liver cancer. 4. Had surgery, ablation or radiotherapy within 1 month. 5. Immunocompromised patients, such as HIV patients. 6. Participate in other clinical studies within 30 days prior to enrollment. 7. Use drugs known to interfere with the drugs used in the test. 8. Any other effective cancer treatments other than those prescribed in the protocol at the start of the study. 9. Lactating patients. 10. The patient has any serious history of non-compliance or inability to give reliable informed consent.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Countries

China

Contacts

Public ContactLin Zhengyu

First Affiliated Hospital of Fujian Medical University

linsilan@aliyun.com+86 13906929229

Outcome results

None listed

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