A Prospective Non-controlled Single-arm Study of TILA-TACE in Treatment of Hepatocellular Carcinoma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tumor Response Rate
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- The response to treatment
- Last Updated
- 7 years ago
Overview
Brief Summary
To validate the tumor response rate: in the previous study, the investigators showed that TILA-TACE achieved 100% tumor response rate. However, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; To validate the overall survival: in the previous study, the investigators showed that TILA-TACE significantly prolonged the overall survival of the patients with large and massive tumor. Again, the sample size was small, the investigators need to validate the data using a large sample size.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hepatocellular carcinoma is confirmed by tissue pathology or in accordance with clinical diagnosis standard;
- •ECOG score 0-1;
- •HCC BCLC grading 0, A, B, C;
- •Child-Pugh score prior to therapy A and B;
- •As judged by investigators, the patient can comply with the study protocol;
- •Patient voluntarily participates in this study, understands the process of the study, and is willing to sign the written consent form.
Exclusion Criteria
- •HCC BCLC grading D;
- •Child-Pugh score prior to therapy C.
Outcomes
Primary Outcomes
The response to treatment
Time Frame: 1 month after therapy
Viable tumors were assessed by MRI according to EASL criteria. The enhanced and non-enhanced areas represent viable and necrotic tumors. At least 2 radiologists evaluate the approximate viable tumor residues (%) of total tumor volume (Total tumor volume was the sum of viable and necrotic volume). The response to treatment is defined by the Viable Tumor Residues (%) as below: complete response (CR), no obvious viable residuals; near complete response (NCR), viable residuals \<10%; partial response (PR), viable residuals \>10% but \< 50%; stable disease (SD), viable tumor residuals between \>50% but ≤100%; and progressive disease (PD), viable tumors \> 100%.
Secondary Outcomes
- Lifetime (months)(6 months once after therapy)