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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021896
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: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 for ge
Keytruda+targeted drug: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. intravenous

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 or 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 index of hepatic arterial chemoembolization; Signs of primary hepatocellular carcinoma in patients; 8. Modified Response Evaluation Criteria for solid tumors in hepatocellular carcinoma In Solid Tumors, mRECIST), there are more than one target tumor that can be evaluated, and at the same time, it meets the following criteria: (1) The lesion was measured with a single diameter greater than or equal to 1cm; (2) The lesion is suitable for repeated measurement; (3) The lesion was presented in contrast-enhanced CT or MRI; Contrast-enhanced arterial development; 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
Objective response rate;Duration of response;Progression-free survival;Overall survival;

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