TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT03996681|
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: methylcantharidimide tablets||Phase 4|
Most guidelines recommend transarterial chemoembolization (TACE), as the standard of care for unresectable hepatocellular carcinoma (HCC ) at Barcelona Clinic Liver Cancer (BCLC) stage A-B. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. The efficacy of TACE on large (≥ 10 cm) stage A-B HCC is far from satisfactory. The median overall survival was only 6.5-9.1 months. Methylcantharidimide is a single molecule drug used for the treatment of primary liver cancer.
Thus, the investigators carried out this prospective trial to demonstrate the efficacy and safety of TACE combined with methylcantharidimide tablets in patients with large and unresectable hepatocellular carcinoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||TACE plus methylcantharidimide tablets|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Clinical Trial of TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular Carcinoma|
|Estimated Study Start Date :||July 20, 2019|
|Estimated Primary Completion Date :||July 20, 2020|
|Estimated Study Completion Date :||February 1, 2021|
Experimental: TACE plus methylcantharidimide tablets
Methylcantharidimide tablets( 75mg po tid) is administered before first TACE 3 days and taken continuously after TACE treatment. Every 6 weeks is a cycle.
Drug: methylcantharidimide tablets
Drug: methylcantharidimide tablets
Methylcantharidimide is a single molecule drug used for the treatment of primary liver cancer.
Transcatheter arterial chemoembolization was performed by the injection of small embolic particles coated with chemotherapeutic agents selectively into an artery directly supplying a tumor.
Other Name: GANYU
- Disease control rate (DCR) [ Time Frame: 18 months ]DCR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), or stable disease (SD). CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or progressive disease (PD) and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
- Time to progression (TTP) [ Time Frame: 18 months ]TTP was defined as the time from the date of treatment to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
- Overall Survival (OS) [ Time Frame: 18 months ]From the date of treatment until the date of death from any cause
- Health Related Quality of Life (HRQoL) [ Time Frame: 18 months ]HRQoL assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) .The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social) and 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, insomnia, constipation, diarrhea and financial difficulties) and a single global health and quality of life status score. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.
- clinical symptoms [ Time Frame: 18 months ]A questionnaire about the clinical symptoms, appetite，pain and sleep.
- Adverse Events [ Time Frame: 18 months ]Postoperative adverse events were graded based on CTCAE v4.03
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996681
|Contact: Lei Chen, MDemail@example.com|
|Contact: Mo Zhou||+86 firstname.lastname@example.org|
|Suzhou Municipal Hospital|
|Suzhou, Jiangsu, China, 215008|
|Contact: Mo Zhou, MD +86 0512-62362596 email@example.com|
|Principal Investigator:||Lei Chen, MD||Suzhou Municipal Hospital|