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Prospective study of pd-1 inhibitor combined with liquid biopsy ctDNA detection combined with targeted drugs and hepatic arterial chemoembolization for the treatment of advanced unresectable liver cancer patients

Prospective study for pd-1 inhibitor combined with liquid biopsy ctDNA detection combined with targeted drugs and hepatic arterial chemoembolization for the treatment of advanced unresectable liver cancer patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021894
Enrollment
Unknown
Registered
2019-03-15
Start date
2018-12-01
Completion date
Unknown
Last updated
2019-03-18

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

Conditions

hepatocelluar carcinoma

Interventions

Opdivo+targeted drug+TACE:Once every 2 weeks Opdivo drug therapy, medicine according to the 3 mg/kg body weight calculation Opdivo dose, intravenous drug. Using the technology of liquid biopsy ctDNA f
Keytruda+targeted drug+TACE:The Keytruda drug treatment group will be given Keytruda drug treatment once every three weeks, with a dose of 200mg, usage and precautions the same as Opdivo drug. intrave

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-75 years old male and female; 2. pre-operative child-pugh level A liver function; 3. stage B or stage C of liver cancer BCLC; 4. ECOG PS score is less than or equal to 1 point; 5. serum hbv-dna of hepatitis b patients <100IU/ml; 6. life expectancy is more than 12 weeks; 7. meeting the diagnostic criteria of the "diagnostic norms for primary liver cancer (2011 edition)" and the treatment of hepatic arterial chemoembolization; Patients with primary hepatocellular carcinoma; 8. according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) of hepatocellular carcinoma, Tumors are no less than 1 target tumor that can be evaluated, and the following Criteria are met: (1) The lesion can be accurately measured, the single diameter should be at least 1cm; (2) The lesion is suitable for repeated measurement; (3) The lesion presented contrast-enhanced arterial enhancement in contrast enhanced CT or MRI; 9. the subjects volunteered to participate in this study, signed the informed consent form, followed up with good compliance.

Exclusion criteria

Exclusion criteria: 1) patients with severe bleeding tendency and not suitable for puncture (PLT 2mg/dl or creatinine clearance rate < 30ml/min; 4) patients with malignant tumors in other parts, organ failure or autoimmune diseases; 5) pregnant or lactating women;An infertile patient who is unwilling or unable to take effective contraceptive measures.

Design outcomes

Primary

MeasureTime frame
Duration of response;Progression-free survival;Overall survival;Objective response rate;

Countries

China

Contacts

Public ContactRuiyun Xu

The Third Affiliated Hospital of Sun Yat-sen University

1798010960@qq.com+86 13809775140

Outcome results

None listed

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