Hepatocellular CarcinomaPhase 2/3HCCNCT04560894
SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma
A Phase 2/3 study testing SCT-I10A, SCT510 and Sorafenib 200mg in people with Hepatocellular Carcinoma, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SCT-I10A, SCT510 and Sorafenib 200mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2020to Sep 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment.
- No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
- Child-Pugh ≤7 , no history of hepatic encephalopathy.
- Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
- At least one measurable lesion based on Recist1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate hematologic and organ function.
Who cannot join
- Local treatment or surgery for liver lesions within 4 weeks.
- Prior liver or other organ transplantation.
- Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
- Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment.
- Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders.
- Active known, or suspected autoimmune disease.
- Any condition that is not suitable for participate in this study as determined by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCT-I10A in Combination With SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC): A Multicenter, Randomized, Open-label,Phase 2/3 Trial
The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SCT-I10A, SCT510, Sorafenib 200mg
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT-I10ADrug
Participants receive SCT-I10A intravenously，200mg，d1，Q3w
SCT510Drug
Participants receive SCT510 intravenously，15mg/kg，d1，Q3w
Sorafenib 200mgDrug
Participants receive sorafenib orally，400mg bid
| Study group | Role | What they receive |
|---|---|---|
| SCT-I10A+SCT510 | Experimental | Not described Receives: Drug: SCT-I10A; Drug: SCT510 |
| Sorafenib | Active comparator | Not described Receives: Drug: Sorafenib 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: up to 3years
Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1
Measured: up to 3years
Secondary outcomes (7)
PFS
PFS evaluated by investigator based on RECIST V1.1
Measured: up to 3years
PFS
PFS evaluated by BICR based on mRECIST.
Measured: up to 3years
Objective response rate (ORR)
ORR evaluated by BICR based on RECIST V1.1.
Measured: up to 3years
ORR
ORR evaluated by BICR based on mRECIST.
Measured: up to 3years
ORR
ORR evaluated by investigator based on RECIST V1.1
Measured: up to 3years
Serum concentration of SCT-I10A and SCT510
Measured: up to 3years
Anti-drug antibody (ADA)
Measured: up to 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start11 Nov 2020
- Primary completionApr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- 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
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560894
- Sponsor's protocol ID
- SCT-I10A-C301
- Acronym
- HCC
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao C, Zhang Y, Wang G, Zheng J, Chen W, Lu Z, Zhuang L, Gu S, Han L, Zheng Z, Yu Z, Yang Y, Sun H, Wei X, Cheng Y, Lin H, Zhu B, Wu G, Lei K, Wang W, Wang Y, Chen K, Xu X, Zheng C, Bi Y, Ding S, Zhang J, Li W, Liu H, Wang J, Liu X, Du Y, Cai L, Wang J, Luo Z, Xing B, Shen J, Yang L, Wu J, Jiang O, Peng Z, Liu X, Cao B, Shen L, Xu A, Li A, Chen S, Fu T, Chen J, Jin C, Zhang L, Lv J, Zhang C, Zhang X, Wang Y, Su H, Zhou Q, Gai W, Xie L, Xu J. Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial. Signal Transduct Target Ther. 2025 Aug 6;10(1):249. doi: 10.1038/s41392-025-02333-5.
PubMed 40769977
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCT-I10A in Combination With SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC): A Multicenter, Randomized, Open-label,Phase 2/3 Trial
- ClinicalTrials.gov ID
- NCT04560894
- Acronym / sponsor ID
- HCC / SCT-I10A-C301
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 23 Sep 2020 (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 the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCT-I10A+SCT510 | Experimental | Drug: SCT-I10A, Drug: SCT510 |
| Sorafenib | Active comparator | Drug: Sorafenib 200mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment.
- No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
- Child-Pugh ≤7 , no history of hepatic encephalopathy.
- Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
- At least one measurable lesion based on Recist1.1
Key exclusion criteria (7 listed)
- Local treatment or surgery for liver lesions within 4 weeks.
- Prior liver or other organ transplantation.
- Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
- Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment.
- Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders.
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 |
|---|---|---|
| SCT-I10AParticipants receive SCT-I10A intravenously，200mg，d1，Q3w | Drug | SCT-I10A+SCT510 |
| SCT510Participants receive SCT510 intravenously，15mg/kg，d1，Q3w | Drug | SCT-I10A+SCT510 |
| Sorafenib 200mgParticipants receive sorafenib orally，400mg bid | Drug | Sorafenib |
Primary outcome
Overall survival (OS)
Time frame: up to 3years
Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1
Time frame: up to 3years
7 secondary outcomes
PFS
Time frame: up to 3years
PFS
Time frame: up to 3years
Objective response rate (ORR)
Time frame: up to 3years
ORR
Time frame: up to 3years
ORR
Time frame: up to 3years
Serum concentration of SCT-I10A and SCT510
Time frame: up to 3years
Anti-drug antibody (ADA)
Time frame: up to 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 40769977Zhao C, Zhang Y, Wang G, Zheng J, Chen W, Lu Z, Zhuang L, Gu S, Han L, Zheng Z, Yu Z, Yang Y, Sun H, Wei X, Cheng Y, Lin H, Zhu B, Wu G, Lei K, Wang W, Wang Y, Chen K, Xu X, Zheng C, Bi Y, Ding S, Zhang J, Li W, Liu H, Wang J, Liu X, Du Y, Cai L, Wang J, Luo Z, Xing B, Shen J, Yang L, Wu J, Jiang O, Peng Z, Liu X, Cao B, Shen L, Xu A, Li A, Chen S, Fu T, Chen J, Jin C, Zhang L, Lv J, Zhang C, Zhang X, Wang Y, Su H, Zhou Q, Gai W, Xie L, Xu J. Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial. Signal Transduct Target Ther. 2025 Aug 6;10(1):249. doi: 10.1038/s41392-025-02333-5.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 SCT-I10A, SCT510 and Sorafenib 200mg in people with Hepatocellular Carcinoma, run by Sinocelltech Ltd. at 1 site 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 3years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560894, which also lists 1 linked publication.
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 1 Feb 2024.