WGc-0201 Plus Tislelizumab in HCC With High Risk of Recurrence and Metastasis After Radical Therapy

NCT ID: NCT07077369

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-12-31

Brief Summary

urgical treatment represents a critical approach for HCC patients to achieve long-term survival, primarily including hepatectomy and liver transplantation. With the increasing implementation of HCC screening in China, the proportion of patients eligible for curative-intent surgical resection or ablation has risen annually. However, the 5-year tumor recurrence and metastasis rate post-surgery remains as high as 50%-70%. Postoperative adjuvant therapy has thus become essential to reduce the risk of recurrence and metastasis and improve patient survival. The target population for postoperative adjuvant therapy mainly comprises HCC patients who are suitable for surgical resection but exhibit high-risk factors for recurrence and metastasis. Currently, no internationally standardized adjuvant treatment regimen exists for patients with high postoperative recurrence and metastasis risks. While immunotherapy has demonstrated benefits for advanced HCC, its role in the adjuvant setting is still under exploration.

Hepatitis B virus (HBV) infection is the primary risk factor for HCC, accounting for at least 50% of global HCC cases. In regions with high HBV prevalence-such as East and Southeast Asia, as well as sub-Saharan Africa-the proportion is even higher. While HBV-related HCC can be prevented through vaccination against HBV infection, no specific precision therapy currently exists for patients already diagnosed with HBV-positive HCC. Given that nucleic acid vaccine technology demonstrates value not only in disease prevention but also in immunotherapy-particularly mRNA therapeutic vaccines-this approach holds promise.

mRNA therapeutic vaccines represent a highly promising new modality for tumor treatment. They offer advantages such as excellent safety, long-term expression, and sustained antigen presentation. Additionally, they can mimic the natural infection process of viruses to activate the immune system, eliciting robust immune responses against tumors. Currently, no mRNA therapeutic vaccines targeting HBV-related antigens have been approved for marketing. WGc-0201 Injection is an mRNA therapeutic vaccine encoding HBV-related specific antigens. Its active ingredient consists of modified mRNA encoding HBV-related antigen proteins, formulated into an injectable preparation via lipid nanoparticle (LNP) encapsulation. Preclinical safety evaluations have demonstrated that this vaccine exhibits low toxicity and good tolerability. Building on these preliminary results, this study aims to further evaluate its potential.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WGc-0201 injection, Dose 1

Group Type: EXPERIMENTAL

WGc-0201 injection

Intervention Type: BIOLOGICAL

WGc-0201 injection

Tislelizumab

Intervention Type: DRUG

Tislelizumab, 200mg

WGc-0201 injection, Dose 2

Group Type: EXPERIMENTAL

WGc-0201 injection

Intervention Type: BIOLOGICAL

WGc-0201 injection

Tislelizumab

Intervention Type: DRUG

Tislelizumab, 200mg

WGc-0201 injection, Dose 3

Group Type: EXPERIMENTAL

WGc-0201 injection

Intervention Type: BIOLOGICAL

WGc-0201 injection

Tislelizumab

Intervention Type: DRUG

Tislelizumab, 200mg

WGc-0201 injection, Dose 4

Group Type: EXPERIMENTAL

WGc-0201 injection

Intervention Type: BIOLOGICAL

WGc-0201 injection

Tislelizumab

Intervention Type: DRUG

Tislelizumab, 200mg

Interventions

WGc-0201 injection

WGc-0201 injection

Intervention Type: BIOLOGICAL

Tislelizumab

Tislelizumab, 200mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with pathologically confirmed hepatocellular carcinoma (HCC);
• Patients who have undergone curative resection or ablation (limited to radiofrequency ablation [RFA] or microwave ablation [MWA]) within 4-12 weeks prior to enrollment: For those who have undergone curative surgical resection, postoperative pathological examination must confirm negative surgical margins (R0 resection); for those who have undergone ablation, complete radiological response must be demonstrated (complete disappearance of arterial enhancement in all ablated tumor lesions);
• Patients with high-risk factors for recurrence and metastasis following curative resection of HCC;
• Positive for hepatitis B surface antigen (HBsAg);
• No extrahepatic metastasis confirmed by contrast-enhanced CT or MRI either before curative resection or postoperatively.

Exclusion Criteria

• Diagnosed with non-hepatocellular carcinoma such as fibrolamellar carcinoma, sarcomatoid carcinoma, or cholangiocarcinoma mixed with hepatocellular carcinoma;
• Evidence of residual tumor, recurrence, or metastasis;
• Clinically significant ascites;
• Received antitumor treatment after curative resection, excluding a single cycle of TACE (transarterial chemoembolization);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiyan Liu

Deputy Director of the Department of Tumor Biological Therapy, West China Hospital, Sichuan University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

WGc-0201/Tislelizumab -HCC

Identifier Type: -

Identifier Source: org_study_id