Advanced Hepatocellular Carcinoma (HCC)Phase 2NCT06309485
Phase 2 Study of WGI-0301 for Advanced HCC
A Phase 2 study testing WGI-0301 at MTD/RP2D dose IV infusion, QW, WGI-0301 at MTD/RP2D -1 dose IV infusion, QW and Sorafenib 400 mg PO, BID continuously in people with Advanced Hepatocellular Carcinoma (HCC), run by Zhejiang Haichang Biotech Co., Ltd. at 9 sites in 2 countries.
Trial summary
The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- WGI-0301 at MTD/RP2D dose IV infusion, QW, WGI-0301 at MTD/RP2D -1 dose IV infusion, QW and Sorafenib 400 mg PO, BID continuously
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 31 Jul 2024to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age on the day of signing informed consent, male or female.
- Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol.
- Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per 2018 AASLD criteria.
- BCLC Stage C or BCLC Stage B with bilobar involvement and infiltrative nature that is only suitable for systemic anti-tumor therapy, and not suitable for any curative surgeries, liver transplantation, or local therapy (BCLC Classification see Appendix 6, Section 14.6).
- Stage 1 only: At least first-line standard treatment failure (disease progression confirmed by imaging) with no available standard treatment options, or unsuitability for standard treatment, or intolerance to standard treatment.
- Stage 2 only: At least first-line standard treatment failure (disease progression confirmed by imaging) or intolerance.
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- Stage 3 only: Patients must have objective radiographic disease progression or intolerance (Intolerance is defined as currently discontinued after ≥28 days of treatment due to toxicity) after only one prior line of systemic immunotherapy treatment with an anti-PD-1/ PD-L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies (Prior locoregional therapy such as surgery, radiofrequency ablation or trans-arterial chemoembolization are also allowed but not counted as systemic therapy, provided that progression has been documented after these therapies, and ≥4 weeks have elapsed since the last therapy).
- Stage 2 and Stage 3: Eligible for treatment with Sorafenib as determined by investigators according to the Package Insert and clinical judgment.
- ECOG PS of 0 or 1 within 7 days prior to the first dose of study intervention.
- Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy including trans-arterial chemoembolization, intra-arterial chemotherapy, ethanol, or radiofrequency ablation; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.
- Life expectancy in the judgement of the Investigator > 12 weeks.
- Recovery to ≤Grade 1 (CTCAE V5.0) from toxicities related to any prior treatments unless the adverse events are clinically non-significant and/ or stable on supportive therapy, such as alopecia, Grade 2 peripheral neuropathy, and hypothyroidism stabilized on hormone replacement therapy.
- Stage 2 and Stage 3:Collection of an archived tissue sample will be requested (where available) or agree to undergo tumor tissue biopsy for biomarker testing; however, a subject will not be precluded from participating in the study if tissue sample is not available for collection or is otherwise insufficient for analysis.
- Patients must have adequate organ function as defined below:
- Child-Pugh Liver Function Class A or Class B (score ≤ 7) (see Appendix 7 in Section 14.7)
- AST and ALT ≤ 3.0 × ULN and total bilirubin ≤ 2 × ULN
- Serum albumin ≥ 2.8 g/ dL
- CrCL ≥ 40 ml/ min (Cockcroft-Gault formula: CrCL (mL/ min) = [140-age(year)] × body weight (Kg)/ [72 × Scr (mg/ dl)]{ × 0.85 for female subjects})
- INR ≤ 2.0 (except for warfarin therapy)
- Hemoglobin ≥ 8.5 g/ dL, absolute neutrophil count > 1000/ mm3, platelet count ≥ 60 000/ mm3(no blood transfusion, blood products, cell growth factors, albumin or any other corrective therapeutic drugs within 14 days)
- Participants with HBV or HCV infection will be allowed if they meet the following criteria:
- HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA < 500 IU/ mL and must should be managed according to treatment guidelines. Those on antiviral therapy at screening should have been treated for >2 weeks before the first dose.
- HCV-HCC: Resolved HCV infection (as evidenced by detectable HCV RNA or antibody), or stable HCV infection (such as normal LFTs or being asymptomatic). Patients with positive HCV RNA requiring direct antiviral agent treatment, or those with HBV and HCV co-infection are excluded.
- WOCBP must have a negative serum pregnancy within 3 days prior to receiving the first dose of study medication and must use accepted highly effective methods of contraception from the time of signing the informed consent through 6 months after the last dose of study drug. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, or be surgically sterile, for the duration of study participation, and for 3 months after completion of study drug administration. See Appendix 1 for protocol-approved highly effective methods of contraceptive combinations.
Who cannot join
- Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.
- Stage 2 and Stage 3: Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein).
- Major surgery within 4 weeks prior to the first dose of study intervention.
- Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs or related excipients.
- Stage 2 and Stage 3: Previous identified allergy or hypersensitivity to components of Sorafenib or similar drugs.
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- Stage 3 only: Received prior Sorafenib therapy or any agents targeting AKT-PI3K pathway.
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention (except for observational clinical trials).
- Locoregional therapy to liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).
- Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose.
- Stage 2 and Stage 3：Patients on concomitant use of strong CYP3A4 inducers (see Appendix 3 in Section 14.3) within 12 days prior to the first dose of study intervention.
- Clinically significant abnormalities of glucose metabolism (e.g., Patients with diabetes mellitus type1 or diabetes mellitus type 2 requiring treatment, or those with HbA1c ≥8.0%.
- Clinically significant cardiovascular disease including:
- Uncontrolled chronic hypertension defined as systolic > 150 mmHg or diastolic > 90 mmHg on more than one measurement despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings prior to enrollment is < 150/ 90 mmHg).
- Hypotension as indicated by systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg on 2 consecutive measurements at the Screening Visit.
- NYHA class III or IV Congestive heart failure, myocardial infarction or stroke, unstable angina pectoris, pericardial effusion (excluding trace pericardial effusion identified by echocardiography), or left ventricular ejection fraction < 45% within 6 months prior to the first dose.
- Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).
- Bradycardia (known history of cardiovascular disease and either physical examination at rest or electrocardiogram indicating heart rate < 50 bpm), or screening ECG indicating QTcF > 470 msec, 2 retests were required for the first abnormal QTcF , and 3 mean values were taken. Or there is severe arrhythmia requiring further treatment, including but not limited to ventricular fibrillation, atrial fibrillation, sustained ventricular tachycardia, second-degree or third-degree atrioventricular block, torsades de pointes, etc.
- Stage 2 and Stage 3: Clinically significant gastrointestinal disorders including:
- Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/ or absorption of the tested products
- Gastrointestinal perforation and/ or fistula intra-abdominal abscess or intestinal obstruction within 6 months prior to the first dose
- Clinically significant gastric bleeding within 6 months prior to the first dose (patients may be enrolled if esophageal and gastric varices are present on imaging, but no bleeding event or inpatient medical intervention occurs within 6 months prior to the first dose)
- Clinically significant bleeding risks including:
- Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hereditary hemorrhagic telangiectasia or von Willebrand disease)
- Bleeding symptoms such as hemoptysis (> 1/ 2 teaspoon bright red blood) and gastrointestinal bleeding within 3 months prior to screening
- Thrombolytic agents within 10 days prior to the first dose
- Receiving anticoagulant therapy (e.g., anticoagulants, antiplatelets), and subject 's INR and APTT are not within expected therapeutic range of anticoagulant (except sodium heparin for maintenance of central venous catheter patency)
- History of solid organ transplant.
- Known HIV or AIDS related illness or is receiving systemic steroid therapy (physiological doses of hormones, such as prednisone <10 mg/day or equivalent doses of similar corticosteroids are acceptable) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- Known active or uncontrolled infection that could interfere with the study (such as requiring intravenous antibiotics, antiviral or antifungal medications).
- Uncontrolled ascites or pleural effusion requiring repeated drainage (Investigator 's judgment).
- Past or current history of neoplasm other than HCC, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 3 years.
- Known CNS or brain metastasis that is either symptomatic or untreated (except for asymptomatic cases not requiring treatment).
- History of drug abuse or addiction at the present stage.
- Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
China8 sites, 8 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha
- Recruiting
West China Hospital Sichuan University
Chengdu
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang
- Recruiting
China Pharmaceutical University, Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, 200131
- Recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan
About this study
Official title: An Open-Label Phase 1/2 Study of WGI-0301 Plus Sorafenib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy
The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.
Read the detailed description
This study will include a two-stage design: Stage 1 (dose escalation) to determine the MTD/RP2D of WGI-0301 combined with Sorafenib. Stage 2 (dose expansion) with two different dose levels of WGI-0301 in combination with standard dose Sorafenib, or standard dose Sorafenib alone.
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Being tested
- WGI-0301 at MTD/RP2D dose IV infusion, QW, WGI-0301 at MTD/RP2D -1 dose IV infusion, QW, Sorafenib 400 mg PO, BID continuously, Sorafenib 400 mg PO, BID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGI-0301 at MTD/RP2D dose IV infusion, QWDrug
WGI-0301 is a lipid nanoparticle preparation of Archexin®, a 20-mer oligonucleotide that is complementary to Akt-1 mRNA, formulated for the treatment of advanced HCC.
WGI-0301 at MTD/RP2D -1 dose IV infusion, QWDrug
WGI-0301 is a lipid nanoparticle preparation of Archexin®, a 20-mer oligonucleotide that is complementary to Akt-1 mRNA, formulated for the treatment of advanced HCC.
Sorafenib 400 mg PO, BID continuouslyDrug
Sorafenib is an oral multi-kinase inhibitor used for the treatment of hepatocellular carcinoma.
Sorafenib 400 mg PO, BIDDrug
Sorafenib is an oral multi-kinase inhibitor used for the treatment of hepatocellular carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | WGI-0301 at MTD / RP2D dose with standard dose Sorafenib Receives: Drug: WGI-0301 at MTD/RP2D dose IV infusion, QW; Drug: Sorafenib 400 mg PO, BID |
| Arm B | Experimental | WGI-0301 at MTD / RP2D -1 dose with standard dose Sorafenib Receives: Drug: WGI-0301 at MTD/RP2D -1 dose IV infusion, QW; Drug: Sorafenib 400 mg PO, BID continuously |
| Arm C | Active comparator | Standard dose Sorafenib alone Receives: Drug: Sorafenib 400 mg PO, BID continuously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1.
ORR is defined as the percentage of patients documented to have a confirmed CR or PR.
Measured: through study completion, an average of 2 year
Secondary outcomes (8)
Safety of each dose group.
Determined by number of AEs, SAEs, number of participant with changes in safety relevant clinical parameters, number of participants with dose modifications.
Measured: through study completion, an average of 2 year
Tolerability of each dose group.
Determined by number of AEs, SAEs, number of participant with changes in safety relevant clinical parameters, number of participants with dose modifications.
Measured: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR.
ORR is defined as the percentage of patients documented to have a confirmed CR or PR.
Measured: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR.
DCR is defined as the percentage of patients documented to have a confirmed CR or PR or SD.
Measured: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DoR.
DoR is defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause in the absence of documented PD.
Measured: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on PFS.
PFS is defined as the time from date of first study treatment to the date of PD or death (by any cause in the absence of progression) regardless of whether the patient withdraws from treatment or receives another anticancer therapy prior to progression.
Measured: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on TTP per RECIST 1.1.
TTP is defined as the time from date of first study treatment to first documented PD.
Measured: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on OS.
OS is defined as the time from date of first study treatment to death due to any cause.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start31 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Haichang Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309485
- Sponsor's protocol ID
- WGI0301-P2G-01
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1/2 Study of WGI-0301 Plus Sorafenib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy
- ClinicalTrials.gov ID
- NCT06309485
- Acronym / sponsor ID
- WGI0301-P2G-01
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang Haichang Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.
Detailed description
This study will include a two-stage design: Stage 1 (dose escalation) to determine the MTD/RP2D of WGI-0301 combined with Sorafenib. Stage 2 (dose expansion) with two different dose levels of WGI-0301 in combination with standard dose Sorafenib, or standard dose Sorafenib alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: WGI-0301 at MTD/RP2D dose IV infusion, QW, Drug: Sorafenib 400 mg PO, BIDWGI-0301 at MTD / RP2D dose with standard dose Sorafenib |
| Arm B | Experimental | Drug: WGI-0301 at MTD/RP2D -1 dose IV infusion, QW, Drug: Sorafenib 400 mg PO, BID continuouslyWGI-0301 at MTD / RP2D -1 dose with standard dose Sorafenib |
| Arm C | Active comparator | Drug: Sorafenib 400 mg PO, BID continuouslyStandard dose Sorafenib alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- ≥18 years of age on the day of signing informed consent, male or female.
- Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol.
- Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per 2018 AASLD criteria.
- BCLC Stage C or BCLC Stage B with bilobar involvement and infiltrative nature that is only suitable for systemic anti-tumor therapy, and not suitable for any curative surgeries, liver transplantation, or local therapy (BCLC Classification see Appendix 6, Section 14.6).
- Stage 1 only: At least first-line standard treatment failure (disease progression confirmed by imaging) with no available standard treatment options, or unsuitability for standard treatment, or intolerance to standard treatment.
Key exclusion criteria (35 listed)
- Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.
- Stage 2 and Stage 3: Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein).
- Major surgery within 4 weeks prior to the first dose of study intervention.
- Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs or related excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WGI-0301 at MTD/RP2D dose IV infusion, QWWGI-0301 is a lipid nanoparticle preparation of Archexin®, a 20-mer oligonucleotide that is complementary to Akt-1 mRNA, formulated for the treatment of advanced HCC. | Drug | Arm A |
| WGI-0301 at MTD/RP2D -1 dose IV infusion, QWWGI-0301 is a lipid nanoparticle preparation of Archexin®, a 20-mer oligonucleotide that is complementary to Akt-1 mRNA, formulated for the treatment of advanced HCC. | Drug | Arm B |
| Sorafenib 400 mg PO, BID continuouslySorafenib is an oral multi-kinase inhibitor used for the treatment of hepatocellular carcinoma. | Drug | Arm B, Arm C |
| Sorafenib 400 mg PO, BIDSorafenib is an oral multi-kinase inhibitor used for the treatment of hepatocellular carcinoma. | Drug | Arm A |
Primary outcome
Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1.
Time frame: through study completion, an average of 2 year
ORR is defined as the percentage of patients documented to have a confirmed CR or PR.
8 secondary outcomes
Safety of each dose group.
Time frame: through study completion, an average of 2 year
Tolerability of each dose group.
Time frame: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR.
Time frame: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR.
Time frame: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DoR.
Time frame: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on PFS.
Time frame: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on TTP per RECIST 1.1.
Time frame: through study completion, an average of 2 year
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on OS.
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WGI-0301 at MTD/RP2D dose IV infusion, QW, WGI-0301 at MTD/RP2D -1 dose IV infusion, QW and Sorafenib 400 mg PO, BID continuously in people with Advanced Hepatocellular Carcinoma (HCC), run by Zhejiang Haichang Biotech Co., Ltd. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Men, MD., Ph.D (+1 2407020080, angela.men@thewogroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1. (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.