Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone

Part of paid clinical trials in Louisville, Kentucky.

Sponsor: Robert C. Martin
Study ID: NCT06526338
Phase: PHASE2
Status: Recruiting

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Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

1.0% IP-001 for injection — DRUG
Participants will receive intratumoral injection of 1.0% IP-001 following local microwave ablation or surgical resection and local microwave ablation
Surgical Resection and Local Ablation — PROCEDURE
Participants will undergo surgical resection of the tumor and local microwave ablation
Local Ablation Alone — PROCEDURE
Participants will have local ablation of the tumor by microwave ablation alone

Study Details

The purpose of this study is to evaluate the safety and efficacy of administration of intratumoral IP-001 injection at different dosages (volume and concentration) following local microwave ablation (MWA) or surgical resection and ablation in patients with hepatocellular carcinoma (HCC).

Key Dates

First listed: Jul 29, 2024
Start date: Jul 24, 2024
Status verified: Sep 2026
Primary completion: Dec 31, 2029
Completion: Dec 31, 2030

Study Design

Enrollment: 315 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Arm A: Participants with ≤3 hepatic tumors that can be treated in one ablation session
Participants will be randomized 1:1:1 to receive intratumoral injection of IP-001 (10 mg/mL, 4 mL \[low volume\]) immediately following local microwave ablation or surgical resection and local microwave ablation
Active Comparator: Arm B: Participants with ≤3 hepatic tumors that can be treated in one ablation session
Participants will be randomized 1:1:1 to receive local microwave ablation or surgical resection and local microwave ablation alone
Experimental: Arm C: Participants with ≤3 hepatic tumors that can be treated in one ablation session
Participants will be randomized 1:1:1 to receive intratumoral injection of IP-001 (10 mg/mL, up to 12 mL \[high volume\]) immediately following local microwave ablation or surgical resection and local microwave ablation
Experimental: Arm D: Participants with >3 hepatic tumors that can be treated in more than one ablation session
Participants will be randomized 1:1 to receive intratumoral injection of IP-001 (10mg/mL \[high concentration\], up to 12 mL) immediately following local microwave ablation or surgical resection and local microwave ablation
Experimental: Arm E: Participants with >3 hepatic tumors that can be treated in more than one ablation session
Participants will be randomized 1:1 to receive intratumoral injection of diluted IP-001 (1 mg/mL \[low concentration\], up to 12 mL) immediately following local microwave ablation or surgical resection and local microwave ablation