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A prospective and exploratory clinical study for the effect prediction and prognosis analysis of circulating tumor cells in the treatment of unresectable middle and advanced stage of HCC

A prospective and exploratory clinical study for the effect prediction and prognosis analysis of circulating tumor cells in the treatment of unresectable middle and advanced stage of HCC

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030502
Enrollment
Unknown
Registered
2020-03-05
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-05-18

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:Simultaneous intensity-modulated radiotherapy combined with apatinib

Sponsors

SanXia Hospital Affiliated to Chongqing University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with TACE insufficiency of inoperable HCC (BCLC stage B and stage C) confirmed by imaging or histology; 2. Aged >=18 years male and female; 3. Child Pugh 5-6 grade A; 4. ECoG score 0-2; 5. The life expectancy exceeds 3 months; 6. Bone marrow function: neutrophil >=1.5x10^9/L, platelet >=75x10^9/L, hemoglobin >=90g/L; 7. Liver and kidney function: serum creatinine <=1.5 ULN; AST and alt <=5 ULN; total bilirubin <=1.5 ULN; 8. BCLC patients in stage B were treated with TACE for 1-2 times at first, once a month. After the last TACE for 1 month, enhanced CT was used to evaluate the insufficient lipiodol deposition and residual enhanced tumor focus; 9. BCLC stage C patients can be enrolled in the group 2 weeks after TACE treatment; 10. Patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial; 2. Patients with sufficient lipiodol deposition and complete remission after TACE treatment; 3. Exclusion of contraindications to antiangiogenic drugs: 1) Those who have high blood pressure and cannot be controlled by antihypertensive drugs; 2) Urine routine showed positive protein = + +; 3) There are many factors that affect oral medicine (inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 4) Abnormal coagulation and bleeding tendency: for example, active ulcer, occult blood in stool (+ +); 5) Grade 3-4 cardiac insufficiency (NYHA standard); 6) Severe hepatorenal insufficiency (grade 4). 4. Having untreated central nervous system disease or symptomatic central nervous system metastasis disease; 5. According to the judgment of researchers, there are serious concomitant diseases endangering the safety of patients or affecting the completion of the study; 6. The estimated survival time is less than 3 months.

Design outcomes

Primary

MeasureTime frame
Time to progress;

Secondary

MeasureTime frame
Objective response rate;Progression free survival;

Countries

China

Contacts

Public ContactLiu Xuefen

SanXia Hospital Affiliated to Chongqing University

lxfpd@sina.com+86 13908263750

Outcome results

None listed

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