A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in the Treatment of Advanced Hepatocellular Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1826, SHR-1826 and immunotherapy combination therapy.
- Who it may be relevant to
- Registry conditions: Hepatocellular Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With Advanced Hepatocellular Cancer
Overview
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.
Interventions
- Drug SHR-1826
SHR-1826 will be administrated per dose level in which the patients are assigned. - Drug SHR-1826 and immunotherapy combination therapy
SHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned.
Primary outcome measures
- Objective Response Rate (ORR) by RECIST V1.1 [Time frame: up 2 years]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Zhongshan Hospital — Shanghai
Identifiers
NCT: NCT06935175 · HCC-2nd-IIT-SHR1826-SHR1316