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A clinical study on the treatment of inoperable middle and advanced stage of HCC with SIB-IMRT low-dose fractionation radiotherapy combined with Apatinib

A clinical study on the treatment of inoperable middle and advanced stage of HCC with SIB-IMRT low-dose fractionation radiotherapy combined with Apatinib

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029551
Enrollment
Unknown
Registered
2020-02-04
Start date
2020-07-01
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

experimental group:SIB-IMRT low-dose fractionation radiotherapy combined with Apatinib

Sponsors

Sanxia Hospital of Chongqing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with inoperable liver cancer (BCLC stage B and stage C) with inadequate TACE confirmed by imaging or histology; 2. Aged >= 18; 3. Child Pugh 5-6 grade A; 4. ECoG score 0-2; 5. The life expectancy exceeds 3 months; 6. Bone marrow function: neutrophil >= 1.5 x 10^9 / L, platelet >= 75 x 10^9 / L, hemoglobin >= 90g / L; 7. Liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and alt <= 5 times the upper limit of normal value; total bilirubin <= 1.5 times the upper limit of normal value; 8. BCLC stage B patients were treated with TACE for 1-2 times, once a month. One month after the last TACE, those with insufficient lipiodol deposition and residual enhanced tumor lesions could be included in the group. 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.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, as well as childbearing age patients who refused to take appropriate contraceptive measures in the course of this 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 influencing oral medicine (inability to swallow, chronic diarrhea and 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
Progression-free Survival;

Secondary

MeasureTime frame
Objective response rate;overall survival;time to progress;

Countries

China

Contacts

Public ContactLiu Xuefen

Sanxia Hospital of Chongqing University

lxfpd@sina.com+86 13908263750

Outcome results

None listed

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