Hepatocellular Carcinoma (HCC)Phase 2/3NCT07392866
A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
A Phase 2/3 study testing SH006, Bevacizumab and Oxaliplatin injection in people with Hepatocellular Carcinoma (HCC), run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- SH006, Bevacizumab and Oxaliplatin injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2026to 1 Mar 2030
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects participate voluntarily and sign informed consent.
- Age ≥ 18 and ≤ 75 years old, male or female.
- Histological or clinical diagnosis of HCC.
- Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment
- Previous treatment with a drug containing an immune checkpoint inhibitor failed.
- Child-Pugh ≤7 , no history of hepatic encephalopathy.
Who cannot join
- Histologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, etc.
- History of malignancy other than HCC within 5 years prior to the start of study treatment.
- History of liver transplantation, or planned to receive liver transplantation.
- Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, 211199
Shukui Qin, 86-13905158713, qinsk81@163.com
Shukui Qin
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jian Zhou, 86-13801914007, zhou.jian@zs-hospital.sh.cn
Jian Zhou
About this study
Official title: A Prospective, Randomized, Active-Controlled, Open-Label, National Multicenter Phase II/III Registration Study of SH006 Injection Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma
Read the detailed description
This is an open, randomized, multicenter study aimed at evaluating the safety and efficacy of SH006 injection (15 mg/kg) in combination with bevacizumab and/or oxaliplatin/capecitabine versus regorafenib in the treatment of patients with advanced hepatocellular carcinoma
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- SH006, Bevacizumab, Oxaliplatin injection, Capecitabine, Regorafenib
- Keywords
- hepatocellular carcinoma, immune checkpoint inhibitors
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH006Drug
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
BevacizumabDrug
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Oxaliplatin injectionDrug
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
CapecitabineDrug
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
RegorafenibDrug
160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 SH006 in combination with bevacizumab and chemotherapy | Experimental | Not described Receives: Drug: SH006; Drug: Bevacizumab; Drug: Oxaliplatin injection; Drug: Capecitabine |
| Arm 2 SH006 in combination with bevacizumab | Experimental | Not described Receives: Drug: SH006; Drug: Bevacizumab |
| Arm 3 SH006 in combination with chemotherapy | Experimental | Not described Receives: Drug: SH006; Drug: Oxaliplatin injection; Drug: Capecitabine |
| Arm 4 Regorafenib | Active comparator | Not described Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) (Phase II)
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 4 years
Incidence of Adverse Events (AEs) (Phase II)
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Measured: Up to approximately 4 years
Overall Survival (OS) (Phase III)
OS was defined as the time from randomization to death due to any cause.
Measured: Up to approximately 4 years
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Disease Control Rate (DCR)
DCR was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Duration of Response (DOR)
DOR was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Time to progression (TTP)
TTP was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392866
- Sponsor's protocol ID
- SHS006-II/III-01
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Active-Controlled, Open-Label, National Multicenter Phase II/III Registration Study of SH006 Injection Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07392866
- Acronym / sponsor ID
- SHS006-II/III-01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, immune checkpoint inhibitors
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 6 Feb 2026 (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.
To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma
Detailed description
This is an open, randomized, multicenter study aimed at evaluating the safety and efficacy of SH006 injection (15 mg/kg) in combination with bevacizumab and/or oxaliplatin/capecitabine versus regorafenib in the treatment of patients with advanced hepatocellular carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 SH006 in combination with bevacizumab and chemotherapy | Experimental | Drug: SH006, Drug: Bevacizumab, Drug: Oxaliplatin injection, Drug: Capecitabine |
| Arm 2 SH006 in combination with bevacizumab | Experimental | Drug: SH006, Drug: Bevacizumab |
| Arm 3 SH006 in combination with chemotherapy | Experimental | Drug: SH006, Drug: Oxaliplatin injection, Drug: Capecitabine |
| Arm 4 Regorafenib | Active comparator | Drug: Regorafenib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects participate voluntarily and sign informed consent.
- Age ≥ 18 and ≤ 75 years old, male or female.
- Histological or clinical diagnosis of HCC.
- Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment
- Previous treatment with a drug containing an immune checkpoint inhibitor failed.
Key exclusion criteria (6 listed)
- Histologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, etc.
- History of malignancy other than HCC within 5 years prior to the start of study treatment.
- History of liver transplantation, or planned to receive liver transplantation.
- Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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 |
|---|---|---|
| SH00615 mg/kg administered as IV infusion on Day 1 of each 21-day cycle | Drug | Arm 1 SH006 in combination with bevacizumab and chemotherapy, Arm 2 SH006 in combination with bevacizumab, Arm 3 SH006 in combination with chemotherapy |
| Bevacizumab15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle | Drug | Arm 1 SH006 in combination with bevacizumab and chemotherapy, Arm 2 SH006 in combination with bevacizumab |
| Oxaliplatin injection85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle | Drug | Arm 1 SH006 in combination with bevacizumab and chemotherapy, Arm 3 SH006 in combination with chemotherapy |
| Capecitabine1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle | Drug | Arm 1 SH006 in combination with bevacizumab and chemotherapy, Arm 3 SH006 in combination with chemotherapy |
| Regorafenib160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle | Drug | Arm 4 Regorafenib |
Primary outcome
Progression-free Survival (PFS) (Phase II)
Time frame: Up to approximately 4 years
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Incidence of Adverse Events (AEs) (Phase II)
Time frame: Up to approximately 4 years
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Overall Survival (OS) (Phase III)
Time frame: Up to approximately 4 years
OS was defined as the time from randomization to death due to any cause.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
Time to progression (TTP)
Time frame: Up to approximately 4 years
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 9 Feb 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SH006, Bevacizumab and Oxaliplatin injection in people with Hepatocellular Carcinoma (HCC), run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 2 sites in China.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jie Min (86-15121121360, minjie@sanhome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (Phase II) (time frame: Up to approximately 4 years). The study lists 3 primary outcomes in all. 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 9 Feb 2026.