TACE With Thermosensitive Nanogel Versus Embosphere for HCC

NCT06593964 | Recruiting DMC

• 1 other identifier: CHANCE-2416
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Transarterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR)

  Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST).

  One month after the last TACE

Secondary Outcomes (5)

• Success rate of target lesion embolization

  One month after the last TACE

• Objective response rate (ORR)

  One month after the last TACE treatment

• Disease control rate (DCR)

  Three and six months after the first TACE

• Equipment performance evaluation

  One month after the first TACE

• Adverse events

  Up to 24 months

Study Arms (2)

TACE with Thermosensitive Nanogel Embolic Agent

EXPERIMENTAL

Equipment: Thermosensitive Nanogel Embolic Agent

Device: Thermosensitive Nanogel Embolic Agent

TACE with Embosphere Microspheres

ACTIVE COMPARATOR

Equipment: Embosphere Microspheres

Device: Thermosensitive Nanogel Embolic Agent

Interventions

Thermosensitive Nanogel Embolic Agent DEVICE

Thermosensitive Nanogel Embolic Agent

TACE with Embosphere Microspheres; TACE with Thermosensitive Nanogel Embolic Agent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;
• Liver function status: Child-Pugh A or B
• Eastern Cooperative Oncology Group score: 0-2 points;
• With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;
• Willing to participate in this trial and sign the informed consent.

You may not qualify if:

• The target lesion has been embolized before or require combined with other treatment(s);
• Diffuse or with extrahepatic metastasis;
• Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);
• Severe renal dysfunctions (creatinine clearance rate \<30 ml/min);
• Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);
• Main portal vein was completely occluded and no collateral blood supply was established;
• With uncorrectable arteriovenous fistula or portal vein fistula;
• Severe cachexia or hepatic encephalopathy;
• With active infection;
• Significant reductions in white blood cells or platelets (white blood cells\<3.0x109/L, platelets\<50x109/L) that cannot be corrected;
• Pregnant or lactating women;
• Difficulty in selective catheterization;
• With the severe risk of non-target embolization;
• Severely allergic to contrast agents or the embolic materials;
• Participating in ongoing trial;

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Gao-Jun Teng

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Gao-Jun Teng, M.D.

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang, M.D.

CONTACT

+86 13770106862; llei589@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)