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An exploratory clinical study on predicting the efficacy of hepatic arterial infusion chemotherapy for unresectable advanced hepatocellular carcinoma based on gene mutations in the DRR pathway

An exploratory clinical study on predicting the efficacy of hepatic arterial infusion chemotherapy for unresectable advanced hepatocellular carcinoma based on gene mutations in the DRR pathway

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038159
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

HCC

Interventions

Gold Standard:Clinical outcomes
of&#32
DDR&#32
signaling&#32

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients (over 18 years old) with unresectable / advanced pathologically confirmed HCC; 2. Patients who failed to receive first-line systemic therapy (chemotherapy, targeted therapy); 3. Patients with ECoG score 0 or 1; 4. Patients with child Pugh liver function grade A or B7; 5. Patients with at least three months' expected survival time; 6. Good liver, kidney and bone marrow function; total bilirubin 750000 / mm3, hemoglobin > 9 g / dl, neutrophil absolute value 1.5 x 500 / mm3; 7. Patients with HBV load less than 2000 IU / ml; 8. Patients without serious cardiopulmonary disease and normal cTnT & CK-MB index; 9. Patients who can provide pathological sections for gene testing and agree to sign the informed consent for research.

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrollable hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg after active treatment); 2. Patients with history of esophageal or gastric bleeding in the last six months; 3. Patients with active infection who need systematic treatment; 4. Patients with previous malignant tumor except liver cancer; 5. Patients with HIV infection history; 6. Patients with history of bleeding or thromboembolism in the last month; 7. Patients who have received bone marrow / hematopoietic stem cell or organ transplantation; 8. The investigator defined the clinical condition as unsuitable for the trial.

Design outcomes

Primary

MeasureTime frame
ORR;ACC, SPE, SEN;

Countries

China

Contacts

Public ContactYin Xin

Zhongshan Hospital Affiliated to Fudan University

yin.xin@zs-hospital.sh.cn+86 13918457694

Outcome results

None listed

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