Hepatocellular CancerPhase 2NCT06935175
A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in the Treatment of Advanced Hepatocellular Cancer
A Phase 2 study testing SHR-1826 and SHR-1826 and immunotherapy combination therapy in people with Hepatocellular Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- SHR-1826 and SHR-1826 and immunotherapy combination therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 May 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18-75 years old, male or female.
- 2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery;
- 3.Failure of at least one line of standard treatment (progression or intolerance);
- 4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion);
- 5.Expected survival time ≥ 12 weeks;
- 6.Normal function of major organs;
- 7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.
Who cannot join
- Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type);
- Evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenaHave central nervous system metastasis;l syndrome, sepsis, etc.;
- Have central nervous system metastasis;
- Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation);
- Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study;
- Other situations in which the investigator deems that the subject should not be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Zhongshan Hospital
Shanghai, 200020
Guoming Shi, M.D, 13916969578, shi.guoming@zs-hospital.sh.cn
About this study
Official title: A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With Advanced Hepatocellular Cancer
The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.
- Conditions
- Hepatocellular Cancer
- Being tested
- SHR-1826, SHR-1826 and immunotherapy combination therapy
- Keywords
- hepatocellular cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1826Drug
SHR-1826 will be administrated per dose level in which the patients are assigned.
SHR-1826 and immunotherapy combination therapyDrug
SHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1826 monotherapy arm | Experimental | Not described Receives: Drug: SHR-1826 |
| SHR-1826 and immunotherapy combination therapy | Experimental | Not described Receives: Drug: SHR-1826 and immunotherapy combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by RECIST V1.1
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Measured: up 2 years
Secondary outcomes (4)
Objective Response Rate (ORR) by mRECIST
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by mRECIST.
Measured: up 2 years
Disease control rate (DCR) by RECIST V1.1
The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).
Measured: up 2 years
Progression-free survival (PFS)
The PFS is defined as Time from the date of enrollment to of disease.
Measured: up 2 years
Overall survival (OS)
The OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Measured: up 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935175
- Sponsor's protocol ID
- HCC-2nd-IIT-SHR1826-SHR1316
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 20 Apr 2025
- 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 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With Advanced Hepatocellular Cancer
- ClinicalTrials.gov ID
- NCT06935175
- Acronym / sponsor ID
- HCC-2nd-IIT-SHR1826-SHR1316
- Conditions
- Hepatocellular Cancer
- Keywords
- hepatocellular cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 20 Apr 2025 (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 study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1826 monotherapy arm | Experimental | Drug: SHR-1826 |
| SHR-1826 and immunotherapy combination therapy | Experimental | Drug: SHR-1826 and immunotherapy combination therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.18-75 years old, male or female.
- 2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery;
- 3.Failure of at least one line of standard treatment (progression or intolerance);
- 4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion);
- 5.Expected survival time ≥ 12 weeks;
Key exclusion criteria (6 listed)
- Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type);
- Evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenaHave central nervous system metastasis;l syndrome, sepsis, etc.;
- Have central nervous system metastasis;
- Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation);
- Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study;
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 |
|---|---|---|
| SHR-1826SHR-1826 will be administrated per dose level in which the patients are assigned. | Drug | SHR-1826 monotherapy arm |
| SHR-1826 and immunotherapy combination therapySHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned. | Drug | SHR-1826 and immunotherapy combination therapy |
Primary outcome
Objective Response Rate (ORR) by RECIST V1.1
Time frame: up 2 years
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
4 secondary outcomes
Objective Response Rate (ORR) by mRECIST
Time frame: up 2 years
Disease control rate (DCR) by RECIST V1.1
Time frame: up 2 years
Progression-free survival (PFS)
Time frame: up 2 years
Overall survival (OS)
Time frame: up 2 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 20 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1826 and SHR-1826 and immunotherapy combination therapy in people with Hepatocellular Cancer, run by Shanghai Zhongshan Hospital 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 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 20 Apr 2025. 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 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 Guoming Shi, M.D (13916969578, shi.guoming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by RECIST V1.1 (time frame: up 2 years). 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 20 Apr 2025.